| CellaVision DC-1, CellaVision DC-1 PPA (K200595) | CellaVision AB | 2020-10-16 |
| X100 with Full Field Peripheral Blood Smear (PBS) Application (K201301) | Scopio Labs , Ltd. | 2020-10-02 |
| BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit (K201814) | Becton, Dickinson and Company | 2020-09-28 |
| HemosIL Liquid Anti-Xa (DEN190032) | Instrumentation Laboratory CO | 2020-09-17 |
| AMICUS Separator System (K200530) | Fresenius Kabi AG | 2020-09-11 |
| PF4 Enhanced assay (K201570) | Immucor Gti Diagnostics, Inc. | 2020-09-11 |
| Quantra QPlus System (K201513) | Hemosonics, LLC | 2020-08-21 |
| HemosIL von Willebrand Factor Antigen (K200033) | Instrumentation Laboratory CO | 2020-08-19 |
| HemoCue Hb 301 System (K201217) | Hemocue AB | 2020-08-04 |
| Cryocheck Chromogenic Factor VIII (K193204) | Precision Biologic | 2020-07-17 |
| PF4 IgG assay (K201311) | Immucor Gti Diagnostics, Inc. | 2020-06-18 |
| Hemo Control (optional Add Pack Hemo Control DM) (K200909) | Ekf-Diagnostic GmbH | 2020-06-12 |
| Unicel DxH 800 Coulter Cellular Analysis System (K193124) | Beckman Coulter | 2020-04-16 |
| Stat Profile Prime Plus Analyzer System (K200204) | Nova Biomedical Corporation | 2020-04-06 |
| Aina HbA1c Monitoring System 2 (K192987) | Jana Care, Inc. | 2020-03-26 |
| BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). (K193393) | Leica Biosystems Newcastle, Ltd. | 2020-03-06 |
| i-STAT CHEM8+ cartridge with the i-STAT 1 System (K183680) | Abbott Point of Care, Inc. | 2020-02-28 |
| T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01 (K191364) | Fujimori Kogyo, Co., Ltd. | 2020-02-14 |
| OC-Auto SENSOR io iFOB Test (K191147) | Eiken Chemical Co., Ltd. | 2020-01-02 |
| Hemochron Signature Elite (K193041) | Accriva Diagnostics, Inc. | 2019-11-22 |
| HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High (K192842) | Eurotrol B.V. | 2019-11-15 |
| Sight OLO (K190898) | Sight Diagnostics , Ltd. | 2019-11-01 |
| PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit (K192369) | Ixensor Co, Ltd. | 2019-10-29 |
| Cytomics FC 500 Series (MPL or MCL) Flow Cytometer (K182886) | Beckman Coulter | 2019-09-06 |
| QNext and DG-PT (K183390) | Diagnostic Grifols, S.A. | 2019-08-21 |
| OneDraw A1C Test System (K183230) | Drawbridge Health, Inc. | 2019-08-15 |
| ADVIA Centaur Erythropoietin (EPO) assay (K183088) | Axis-Shield Diagnostics Limited | 2019-08-02 |
| SwimCount Sperm Quality Test (K183602) | Motilitycount Aps | 2019-06-27 |
| TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge (K183160) | Haemonetics Corporation | 2019-05-09 |
| PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit (K181915) | Ixensor Co, Ltd. | 2019-04-12 |
| AggreGuide A-100 ADP (K181777) | Aggredyne, Inc. | 2019-03-29 |
| ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer (K183592) | Beckman Coulter | 2019-03-21 |
| CELL-DYN Emerald 22 AL System (K190294) | Abbott Laboratories | 2019-03-15 |
| Quantra Hemostasis Analyzer, QPlus Cartridge (DEN180017) | Hemosonics, LLC | 2019-03-12 |
| CRYOcheck FVIII Inhibitor Kit (K183440) | Precision Biologic, Inc. | 2019-03-12 |
| DxH 520 Hematology Instrument (K181475) | Beckman Coulter | 2019-03-01 |
| Coag-Sense Prothrombin Time (PT) / INR Monitoring Device (K183255) | Coagusense, Inc. | 2019-02-21 |
| Quo-Test A1c System (K180509) | Ekf-Diagnostic GmbH | 2019-02-16 |
| HemoCue Hb 801 System (K181751) | Hemocue AB | 2019-02-01 |
| HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High (K182744) | Eurotrol B.V. | 2019-02-01 |
| Sysmex XN-L Automated Hematology Analyzer (K182389) | Sysmex America, Inc. | 2019-01-25 |
| microINR System (K180780) | Iline Microsystems, S.L. | 2019-01-25 |
| CAPI 3 HEMOGLOBIN(E) (K180762) | Sebia | 2018-12-14 |
| BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody (K183102) | Leica Biosystems Newcastle, Limited | 2018-12-07 |
| Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra (K183100) | Leica Biosystems Newcastle, Limited | 2018-12-07 |
| LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer (K180343) | Bonraybio Co., Ltd. | 2018-11-16 |
| hemochroma PLUS System (K182298) | Immunostics Inc., | 2018-11-16 |
| Athelas One (K181288) | Athelas, Inc. | 2018-11-05 |
| Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device (K182062) | Sysmex America, Inc. | 2018-10-30 |
| HemoScreen Hematology Analyzer (K180020) | Pixcell Medical Technologies, Ltd. | 2018-10-29 |
| Diazyme 1,5-AG Assay (K180209) | Diazyme Laboratories, Inc. | 2018-10-04 |
| Kawasumi Laboratories Blood Drawing Kit (BDK) System (K172957) | Kawasumi Laboratories, Inc. | 2018-09-28 |
| skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) (K173127) | Skyla Corporation H.S.P.B | 2018-09-25 |
| INNOVANCE Free PS Ag (K181525) | Siemens Healthcare Diagnostics Products GmbH | 2018-09-07 |
| Stat Profile Prime Plus Analyzer System (K180186) | Nova Biomedical Corporation | 2018-08-23 |
| CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set (K173202) | Sekisui Medical Co., Ltd. | 2018-05-09 |
| Sysmex UF-5000 Fully Automated Urine Particle Analyzer (K171883) | Sysmex America, Inc. | 2018-04-23 |
| CoaguChek XS Plus System (K180684) | Roche Diagnostics | 2018-04-19 |
| CoaguChek XS Pro System (K180693) | Roche Diagnostics | 2018-04-19 |
| DiaSpect Tm, DiaSpect Tm Cuvettes (K172173) | Ekf-Diagnostic GmbH | 2018-04-06 |
| HemosIL Factor XII Deficient Plasma (K180486) | Instrumentation Laboratory CO | 2018-03-22 |
| cobas m 511 integrated hematology analyzer (K171655) | Roche Diagnostics Hematology, Inc. | 2018-03-02 |
| ACE Hemoglobin A1c (HbA1c) Reagent (K170623) | Alfa Wassermann Diagnostic Technologies, LLC | 2018-02-27 |
| Instant-view-PLUS immunochemical Fecal Occult Blood Test (K173212) | Alfa Scientific Designs, Inc. | 2018-02-15 |
| cobas Factor II and Factor V Test (K172913) | Roche Molecular Systems, Inc. | 2018-01-12 |
| CoaguChek Vantus System (K170960) | Roche Diagnostics | 2017-12-25 |
| FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) (K170028) | Dako Denmark A/S | 2017-12-21 |
| FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) (K170005) | Dako Denmark A/S | 2017-12-21 |
| Automated Blood Coagulation Analyzer CS-2500 (K172286) | Siemens Healthcare Diagnostic Products GmbH | 2017-12-18 |
| HemosIL D-Dimer HS 500 (K172903) | Instrumentation Laboratory CO | 2017-11-22 |
| Alere Afinion HbA1c and ACR on Afinion 2 analyzer (K171650) | Abbott Rapid Diagnostics | 2017-11-21 |
| Trak Plus Male Fertility Testing System (K172514) | Sandstone Diagnostics, Inc. | 2017-11-17 |
| XW-100 Automated Hematology Analyzer for CLIA Waived Use (K172604) | Sysmex America, Inc. | 2017-11-06 |
| ABX MICROS ES 60 OT and ABX MICROS ES 60 CT (K170353) | HORIBA ABX SAS | 2017-11-01 |
| Sysmex CS-5100 (K172333) | Siemens Healthcare Diagnostics Products GmbH | 2017-10-31 |
| Lucica Glycated Albumin-L (K170147) | Asahi Kasei Pharma Corporation | 2017-10-12 |
| InSure ONE (K170548) | Enterix, Inc. | 2017-10-05 |
| AnemoCheck (K163215) | Sanguina, LLC | 2017-09-13 |
| Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software (K171664) | Bio-Rad Laboratories, Inc. | 2017-09-13 |
| hemochroma PLUS System (K163465) | Immunostics Inc., | 2017-09-08 |
| HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls (K170854) | Instrumentation Laboratory CO | 2017-09-08 |
| i-STAT Hematocrit test with i-STAT Alinity System (K163342) | Abbott Laboratories | 2017-08-22 |
| INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls (K162540) | Siemens Healthcare Diagnostics Prodcts GmbH | 2017-08-22 |
| ADVIA 2120i, ADVIA 2120 (K162977) | Siemens Healthcare Diagnostics | 2017-08-11 |
| AFIAS iFOB with AFIAS-50 (K163225) | Immunostics Inc., | 2017-08-08 |
| Advanced RBC Application (K171315) | CellaVision AB | 2017-08-01 |
| cobas HbA1c Test, cobas b 101 system (K163633) | Roche Diagnostics Operations | 2017-07-28 |
| BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (K171753) | Leica Biosystems Newcastle, Limited | 2017-07-21 |
| BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK (K170974) | Becton, Dickinson and Company | 2017-07-03 |
| ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M (DEN160047) | Beckman Coulter | 2017-06-29 |
| Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser (K162897) | Beckman Coulter | 2017-06-23 |
| VALIDATE D-Dimer Calibration Verification / Linearity Test Kit (K170864) | Maine Standards Company, LLC | 2017-06-21 |
| A1C EZ Glycohemoglobin Analysis System (K161533) | Biohermes Co., Ltd. | 2017-06-16 |
| hema-screen SPECIFIC Gold (K171484) | Immunostics Inc., | 2017-06-14 |
| Wondfo One Step Fecal Occult Blood (FOB) Test (K162333) | Guangzhou Wondfo Biotech Co., Ltd. | 2017-05-14 |
| TEG 6s Hemostasis System (K160502) | Haemonetics Corporation | 2017-04-19 |
| AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument (K163274) | Aggredyne, Inc. | 2017-04-05 |
| VALIDATE Heparin Calibration Verification/Linearity Test Kit (K163498) | Maine Standards Company, LLC | 2017-03-16 |
| ACL AcuStar (K170314) | Instrumentation Laboratory CO | 2017-03-03 |
| Dextramer CMV Kit (K153538) | Immudex Aps | 2017-03-02 |