| George King Coumadin Plasma (K161316) | George King Bio-Medical, Inc. | 2017-02-23 |
| CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) (K162281) | Sebia | 2017-02-17 |
| hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test (K163554) | Immunostics Inc., | 2017-01-17 |
| VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit (K162705) | Maine Standards Company, LLC | 2017-01-05 |
| Sysmex CS-2100i (K162688) | Siemens Healthcare Diagnostics Products GmbH | 2016-12-26 |
| XN CAL (K160585) | Streck | 2016-12-22 |
| XN CHECK BF (K160588) | Streck | 2016-12-22 |
| XN CHECK (K160590) | Streck | 2016-12-22 |
| XN-L CHECK (K160586) | Streck | 2016-12-22 |
| Sysmex XN-L Automated Hematology Analyzer (K160538) | Sysmex America, Inc. | 2016-12-22 |
| GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) (K160415) | Instrumentation Laboratory CO | 2016-12-14 |
| Sysmex Automated Blood Coagulation Analyzer CS-5100 (K162420) | Siemens Healthcare Diagnostics Products GmbH | 2016-12-12 |
| STA® - Liatest® D-Di (K162227) | Diagnostica Stago | 2016-12-10 |
| Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel (K161329) | Chrono-Log Corp. | 2016-12-02 |
| UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System (K162414) | Beckman Coulter, Inc. | 2016-11-29 |
| AMICUS Separator System, AMICUS Separator System; Refurbished (K162462) | Fresenius Kabi USA,Llc | 2016-11-23 |
| Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set (K160762) | Diazyme Laboratories | 2016-11-21 |
| YO Home Sperm Test (K161493) | Medical Electronic Systems , Ltd. | 2016-11-08 |
| HemosIL D-Dimer HS (K160885) | Instrumentation Laboratory CO | 2016-10-27 |
| Xprecia Stride Coagulation System, Xprecia System PT Controls (K151964) | Siemens Healthcare Diagnostics | 2016-09-30 |
| Sysmex Automated Blood Coagulation Analyzer CS-5100 (K161317) | Siemens Healthcare Diagnostics Products GmbH | 2016-09-02 |
| BC-5D Hematology Control (K160606) | R&D Systems, Inc. | 2016-09-01 |
| Sysmex Automated Blood Coagulation Analyzer CS-2100i (K161312) | Siemens Healthcare Diagnostics Products GmbH | 2016-09-01 |
| BC-5390 Auto Hematology Analyzer (K160429) | Mindray Bio-Medical Electronics Co., Ltd. | 2016-09-01 |
| HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls (K153137) | Instrumentation Laboratory CO | 2016-07-08 |
| BinaxNOW G6PD Test (K161364) | Alere Scarborough, Inc. | 2016-06-17 |
| VALIDATE D-Dimer Calibration Verification/Linearity Test Kit (K152961) | Maine Standards Company, LLC | 2016-06-03 |
| Glocyte Automated Cell Counter System (K152776) | Advanced Instruments, Inc. | 2016-05-27 |
| Trak Male Fertility Testing System (K153683) | Sandstone Diagnostics, Inc. | 2016-05-16 |
| FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) (K160922) | Dako North America, Inc. | 2016-05-03 |
| HemosIL Silica Clotting Time (K160445) | Instrumentation Laboratory CO | 2016-03-16 |
| VisuCon-F Low Fibrinogen Control Plasma (K150144) | Affinity Biologicals, Inc. | 2016-03-06 |
| ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) (K160276) | Instrumentation Laboratory CO | 2016-03-03 |
| Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set (K143470) | Diazyme Laboratories | 2016-01-31 |
| URight Hemoglobin A1c system, FORA A1c System (K142664) | Taidoc Technology Corporation | 2016-01-29 |
| Sysmex Automated Blood Coagulation Analyzer CS-2100i (K151259) | Siemens Healthcare Diagnostics Products GmbH | 2016-01-26 |
| Sysmex Automated Blood Coagulation Analyzer CS-5100 (K150678) | Siemens Healthcare Diagnostic Products GmbH | 2016-01-11 |
| BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit (K150815) | Becton, Dickinson and Company | 2015-12-17 |
| ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS (K150877) | Instrumentation Laboratory CO | 2015-12-13 |
| PENTRA XLR (K151133) | HORIBA ABX SAS | 2015-12-09 |
| XW-100 Automated Hematology Analyzer, XW QC CHECK (K143577) | Sysmex America, Inc. | 2015-10-12 |
| SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set (K140827) | Sd Biosensor, Inc. | 2015-09-30 |
| Alere Afinion HbA1c, Alere Afinion AS100 Analyzer (K151809) | Alere Technologies AS | 2015-09-25 |
| BC-3600 Auto Hematology Analyzer (K143348) | Mindray Bio-Medical Electronics Co., Ltd. | 2015-08-21 |
| OC-Light S FIT (K143325) | Eiken Chemical Co., Ltd. | 2015-08-20 |
| STA R MAX (K151867) | Diagnostica Stago S.A.S | 2015-08-07 |
| ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST (K141427) | Accumetrics, Inc. | 2015-07-24 |
| Virtuoso System for IHC PR (1E2) using iScan HT (K142965) | Ventana Medical Systems, Inc. | 2015-07-16 |
| HemosIL D-Dimer HS (K151534) | Instrumentation Laboratory CO | 2015-07-06 |
| CORA (Coagulation Resonance Analysis) System (K150041) | Coramed Technologies, LLC | 2015-06-26 |
| AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS (K141932) | Beckman Coulter, Inc. | 2015-04-10 |
| HOME ACCESS AIC TEST (K141944) | Home Access Health Corp. | 2015-03-13 |
| BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) (K141468) | Bd Biosciences | 2015-02-27 |
| GENASIS HIPATH IHC FAMILY (K140957) | Applied Spectral Imaging , Ltd. | 2015-01-15 |
| CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY (K140893) | Coramed Technologies, LLC | 2015-01-03 |
| ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL) (K141161) | HORIBA ABX SAS | 2014-12-20 |
| A1c iGear System (K142789) | Sakae Corporation | 2014-12-16 |
| POOL NORM (K142132) | Diagnostics Stago S.A.S. | 2014-12-12 |
| XN CHECK (K141964) | Streck | 2014-12-05 |
| XN CAL (K141962) | Streck | 2014-12-05 |
| SYSMEX XN SERIES (K141681) | Sysmex America, Inc. | 2014-12-05 |
| XN CAL PF (K141955) | Streck | 2014-12-05 |
| XN CHECK BF (K141957) | Streck | 2014-12-05 |
| UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM (K140911) | Beckman Coulter, Inc. | 2014-09-05 |
| STA LIATEST D-DI (K141144) | Diagnostica Stago | 2014-09-03 |
| HEMOSIL D-DIMER HS 500 CONTROL (K133582) | Instrumentation Laboratory | 2014-08-15 |
| DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT (K133803) | Diazyme Laboratories | 2014-08-06 |
| APERIO EPATHOLOGY EIHC IVD SYSTEM (K141109) | Leica Biosystems Imaging, Inc. | 2014-07-29 |
| HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM (K141750) | Infopia Co, Ltd. | 2014-07-24 |
| UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT (K140829) | Beckman Coulter, Inc. | 2014-07-14 |
| VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM (K140801) | Bio-Rad Laboratories, Inc. | 2014-06-25 |
| IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST (K132978) | Sequenom, Inc. | 2014-06-13 |
| VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) (K122556) | Leica Biosystems Newcastle, Ltd. | 2014-05-19 |
| I-CHROMA IFOB WITH I-CHROMA READER (K132167) | Boditech Med, Inc. | 2014-05-02 |
| A1C GEAR SYSTEM (K130014) | Sakae Corporation | 2014-04-04 |
| OMNYX IDP FOR HER2 MANUAL APPLICATION (K131140) | Omnyx, LLC | 2014-04-01 |
| MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS (K133344) | Sebia | 2014-03-28 |
| VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER (K140465) | Ventana Medical Systems, Inc. | 2014-03-20 |
| HEMOSIL VON WILLEBRAND ACTIVITY ASSAY (K133005) | Instrumentation Laboratory CO | 2014-03-13 |
| ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR (K131307) | Siemens Healthcare Diagnostics, Inc. | 2014-01-24 |
| HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) (K132722) | Instrumentation Laboratory CO | 2014-01-22 |
| REAGENT, RUSSEL VIPER VENOM - LA CONFIRM (K132076) | Dsrv, Inc. | 2014-01-10 |
| REAGENT, RUSSEL VIPER VENOM - LA SCREEN (K132130) | Dsrv, Inc. | 2014-01-10 |
| AGGREGUIDE (K122162) | Aggredyne, Inc. | 2013-12-20 |
| MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) (K130861) | Dako North America, Inc. | 2013-12-09 |
| VIRTUOSO SYSTEM FOR IHC ER (SPI) (K130515) | Ventana Medical Systems, Inc. | 2013-11-22 |
| VIRTUOSO SYSTEM FOR IHC HER2 (4B5) (K121516) | Ventana Medical Systems, Inc. | 2013-09-26 |
| PHILIPS HERCEPTEST DIGITAL SCORE (K130021) | Philips Medical Systems Nederland B.V. | 2013-09-19 |
| VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER (K122143) | Ventana Medical Systems, Inc. | 2013-09-19 |
| NAVIOS FLOW CYTOMETER SYSTEM (K130373) | Beckman Coulter, Inc. | 2013-09-18 |
| VYSIS D7S486/CEP 7 FISH PROBE KIT (K131508) | Abbott Molecular, Inc. | 2013-09-13 |
| VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) (K121033) | Ventana Medical Systems, Inc. | 2013-09-06 |
| MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM (K122553) | ACON Laboratories, Inc. | 2013-08-05 |
| VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) (DEN130010) | Abbott Molecular, Inc. | 2013-07-29 |
| TETRACHROME REAGENTS AND TETRACXP SYSTEM (K121445) | Beckman Coulter, Inc. | 2013-07-26 |
| R&D 5D RETIC HEMATOLOGY CONTROL (K130962) | R&D Systems, Inc. | 2013-07-24 |
| DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC (K120977) | International Technidyne Corp. | 2013-07-03 |
| I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 (K120900) | Cliniqa Corporation | 2013-05-31 |
| EUROTROL HEMATOCRIT CONTROL (K121467) | Eurotrol B.V. | 2013-05-10 |
| VARIANT(TM) II TURBO HBA1C KIT - 2.0 (K130990) | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 2013-05-09 |