| ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator (K160724) | Siemens Healthcare Diagnostics, Inc. | 2016-09-07 |
| ACCU-CHEK Guide Blood Glucose Monitoring System (K160944) | Roche Diabetes Care, Inc. | 2016-08-31 |
| iHealth Align Gluco-Monitoring system (K153286) | Andon Health Co, Ltd. | 2016-08-19 |
| Wireless Smart Gluco-Monitoring System (K153278) | Andon Health Co, Ltd. | 2016-08-19 |
| Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems (K153651) | Beckman Coulter, Inc. | 2016-08-18 |
| ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls (K153375) | Abbott Laboratories | 2016-08-12 |
| Audit MicroControls Linearity DROP LQ Blood Glucose (K161874) | Aalto Scientific, Ltd. | 2016-08-10 |
| On Call Pro Blood Glucose Monitoring System (K161867) | Acon Laboratories | 2016-08-05 |
| UniStrip1 Generic Blood Glucose Test Strips (K160038) | Ok Biotech Co., Ltd. | 2016-07-29 |
| Tina-quant Cystatin C Gen.2 (K161817) | Roche Diagnostics Operations (Rdo) | 2016-07-27 |
| ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) (K160757) | Axis-Shield Diagnostics Limited | 2016-07-26 |
| URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (K160372) | Teco Diagnostics, Inc. | 2016-07-22 |
| PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System (K152599) | Ok Biotech Co., Ltd. | 2016-07-20 |
| EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control (K151978) | Edan Instruments, Inc. | 2016-07-15 |
| i-STAT Alinity System with i-STAT Sodium test (K153357) | Abbott Point of Care, Inc. | 2016-07-08 |
| LIAISON EBV IgM Serum Control Set (K161522) | DiaSorin, Inc. | 2016-06-30 |
| LIAISON CMV IgM Serum Control Set (K161526) | DiaSorin, Inc. | 2016-06-30 |
| ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) (K161495) | Luminex Corporation | 2016-06-30 |
| ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material (K151986) | Siemens Healthcare Diagnostics, Inc. | 2016-06-29 |
| Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer (K153692) | Infrared Laboratory Systems, LLC (Dba Synermed) | 2016-06-24 |
| Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System (K160430) | Ascensia Diabetes Care U.S., Inc. | 2016-06-24 |
| SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System (K153201) | Sd Biosensor | 2016-06-24 |
| StatStrip Xpress Blood Glucose Monitoring System (K160156) | Nova Biomedical Corporation | 2016-06-23 |
| BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer (K160370) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016-06-09 |
| NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit (K153165) | Astute Medical, Inc. | 2016-06-01 |
| IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 (K160647) | Siemens Healthcare Diagnostics, Inc. | 2016-05-31 |
| ORAcollect.Dx (K152464) | DNA Genotek, Inc. | 2016-05-26 |
| Oragene Dx (K152556) | DNA Genotek, Inc. | 2016-05-26 |
| Creatine Kinase (K160570) | Roche Diagnostics Operations (Rdo) | 2016-05-25 |
| VITROS Chemistry Products Calibrator Kit 3 (K161140) | Ortho-Clinical Diagnostics, Inc. | 2016-05-20 |
| IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers (K161082) | Immunodiagnostic Systems , Ltd. | 2016-05-17 |
| Elecsys Cortisol II, Cortisol II CalSet (K152227) | Roche Diagnostics | 2016-04-27 |
| POGO Automatic Blood Glucose Monitoring System (K152493) | Intuity Medical, Inc. | 2016-04-25 |
| CueSee Hypoxic (K152553) | Eurotrol B.V. | 2016-04-22 |
| AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System (K152365) | Agamatrix, Inc. | 2016-04-21 |
| Dropper hsCRP High Sensitivity CRP Control (K152117) | Quantimetrix Corporation | 2016-04-21 |
| Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators (K153361) | Fujirebio Diagnostics,Inc. | 2016-04-15 |
| ARIES System (K160517) | Luminex Corporation | 2016-04-12 |
| Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test (K142754) | Sugentech, Inc. | 2016-04-07 |
| TRUE METRIX GO Self Monitoring Blood Glucose System (K143548) | Trividia Health, Inc. | 2016-04-01 |
| URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (K152835) | Teco Diagnostics, Inc. | 2016-03-07 |
| Liquid CO2-2 (LCO2-2) (K152085) | Randox Laboratories, Ltd. | 2016-02-24 |
| Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip (K152768) | Assure Tech. Co., Ltd. | 2016-02-24 |
| FreeStyle Precision Neo H Blood Glucose Monitoring System (K153330) | Abbott Diabetes Care, Inc. | 2016-02-19 |
| ST AIA-PACK hsE2 Calibrator Set (K160113) | Tosoh Bioscience, Inc. | 2016-02-17 |
| FREND™ Free T4 Test System (K152422) | Nanoentek USA, Inc. | 2016-02-17 |
| Direct Bilirubin (K152343) | Randox Laboratories Limited | 2016-02-16 |
| BD Vacutainer UltraTouch Push Button Blood Collection Set (K153309) | Becton, Dickinson and Company | 2016-02-12 |
| Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator (K151529) | Siemens Healthcare Diagnostics, Inc. | 2016-02-11 |
| ARCHITECT SHBG (K152185) | Biokit, S.A. | 2016-02-11 |
| VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit (K153712) | Radiometer America, Inc. | 2016-01-28 |
| Total Bilirubin (K152344) | Randox Laboratories Limited | 2016-01-28 |
| StatStrip Xpress 2 Glucose Hospital Meter System (K152986) | Nova Biomedical Corporation | 2016-01-27 |
| Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method (K151487) | Diatron U.S., Inc. | 2016-01-14 |
| MyGlucoHealth Wireless System (K143169) | Entra Health Systems | 2016-01-08 |
| Direct HDL Cholesterol (HDL) (K153435) | Randox Laboratories, Ltd. | 2016-01-08 |
| TIVA¿ (K152924) | Velano Vascular | 2016-01-07 |
| Dario Blood Glucose Monitoring System (K150817) | Labstyle Innovations, Ltd. | 2015-12-21 |
| ST AIA-PACK PROG III Calibrator Set (K153417) | Tosoh Bioscience, Inc. | 2015-12-18 |
| ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator (K153365) | Siemens Healthcare Diagnostics, Inc. | 2015-12-18 |
| ARCHITECT 2nd Generation Testosterone (K152155) | Abbott Laboratories | 2015-12-17 |
| PRODIGY iConnect Blood Glucose Monitoring System (K142785) | Ok Biotech Co., Ltd. | 2015-12-17 |
| Freestyle Freedom Blood Glucose Monitoring Sytem (K152442) | Abbott Laboratories | 2015-12-17 |
| OneTouch Ultra Plus Flex Blood Glucose Monitoring System (K151611) | Lifescan Europe | 2015-12-14 |
| Liquichek Cardiac Markers Plus Control LT (K150300) | Bio-Rad Laboratories | 2015-12-11 |
| Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator (K151767) | Siemens Healthcare Diagnostics, Inc. | 2015-12-11 |
| D-100 HbA1c, D-100 HbA1c Calibrator Pack (K151321) | Bio-Rad Laboratories, Inc. | 2015-12-09 |
| ABL80 FLEX and ABL80 FLEX CO-OX (K151639) | Sendx Medical, Inc. | 2015-12-07 |
| iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System (K150833) | Andon Health Co, Ltd. | 2015-12-04 |
| Gmate Origin Blood Glucose Monitoring System (K151658) | Philosys, Inc. | 2015-12-01 |
| Cortisol Saliva Luminescence Immunoassay (K150528) | Ibl International GmbH | 2015-11-25 |
| Contour Next USB Blood Glucose Monitoring System (K150942) | Bayer Healthcare | 2015-11-25 |
| SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System (K151265) | Sd Biosensor | 2015-11-24 |
| Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System (K151792) | Siemens Healthcare Diagnostics, Inc. | 2015-11-20 |
| Gmate SMART Blood Glucose Monitoring System (K150299) | Philosys, Inc. | 2015-11-19 |
| Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) (K150168) | Siemens Healthcare Diagnostics | 2015-11-04 |
| ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set (K150270) | Tosoh Bioscience, Inc. | 2015-10-26 |
| Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips (K150396) | Apex BioTechnology Corp. | 2015-10-14 |
| Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring System (K140325) | Joinsoon Medical Technology Co, Ltd. | 2015-10-13 |
| ARIES System (K151917) | Luminex Corporation | 2015-10-06 |
| One Step hCG Pregnancy Test (K150063) | Coretests, Inc. | 2015-10-02 |
| GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM (K141656) | Philosys, Inc. | 2015-10-02 |
| Elecsys Progesterone III CalSet (K152526) | Roche Diagnostics | 2015-10-02 |
| FreeStyle Precision Neo Blood Glucose Monitoring System (K142928) | Abbott Diabetes Care, Inc. | 2015-09-30 |
| U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System (K151100) | Taidoc Technology Corporation | 2015-09-29 |
| Cholesterol (K150654) | Randox Laboratories, Ltd. | 2015-09-29 |
| Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet (K151786) | Roche Diagnostics | 2015-09-24 |
| Contour Next Control Solution (K151742) | Bayer Healthcare | 2015-09-23 |
| Dimension Vista MMB Assay (K143720) | Siemens Healthcare Diagnostics | 2015-09-18 |
| FreeStyle InsuLinx Blood Glucose Monotioring System (K152328) | Abott Laboratories | 2015-09-17 |
| Stat Profile Prime ABG Analyzer System (K151982) | Nova Biomedical Corporation | 2015-09-10 |
| PAXgene Blood DNA Tube (K142821) | Preanalytix GmbH | 2015-09-09 |
| On Call Express Pro Blood Glucose Monitoring System (K151595) | ACON Laboratories, Inc. | 2015-09-05 |
| GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System (K150274) | Infopia Co, Ltd. | 2015-08-26 |
| 25-Hydroxy Vitamin Ds EIA (K142351) | Immunodiagnostic Systems , Ltd. | 2015-08-25 |
| Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream (K150022) | Guangzhou Wondfo Biotech Co., Ltd. | 2015-08-07 |
| Assure Prism multi Blood Glucose Monitoring System (K151164) | I-Sens, Inc. | 2015-08-07 |
| GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System (K142689) | Apex BioTechnology Corp. | 2015-08-06 |
| Triglycerides (K150819) | Randox Laboratories Limited | 2015-08-06 |
| ABL80 FLEX CO-OX with AQURE connectivity (K151856) | Sendx Medical, Inc. | 2015-08-06 |