Review Panel
Hematology FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,197
- Product Codes (page)
- 34
- Latest Decision
- 2020-11-06
Clearances · page 2 of 42
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K200811 | cobas u 701 microscopy analyzer | Roche Diagnostics | LKM | Class II | 2020-11-06 |
| K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | POV | Class II | 2020-10-28 |
| K193556 | Cryocheck Hex LA | Precision Biologic | GFO | Class II | 2020-10-23 |
| K200595 | CellaVision DC-1, CellaVision DC-1 PPA | CellaVision AB | JOY | Class II | 2020-10-16 |
| K201301 | X100 with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | JOY | Class II | 2020-10-02 |
| K201814 | 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 | Becton, Dickinson and Company | OYE | Class II | 2020-09-28 |
| DEN190032 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | QLU | Class II | 2020-09-17 |
| K200530 | AMICUS Separator System | Fresenius Kabi AG | GKT | Class II | 2020-09-11 |
| K201570 | PF4 Enhanced assay | Immucor Gti Diagnostics, Inc. | LCO | Class II | 2020-09-11 |
| K201513 | Quantra QPlus System | Hemosonics, LLC | QFR | Class II | 2020-08-21 |
| K200033 | HemosIL von Willebrand Factor Antigen | Instrumentation Laboratory CO | GGP | Class II | 2020-08-19 |
| K201217 | HemoCue Hb 301 System | Hemocue AB | GKR | Class II | 2020-08-04 |
| K193204 | Cryocheck Chromogenic Factor VIII | Precision Biologic | GGP | Class II | 2020-07-17 |
| K201311 | PF4 IgG assay | Immucor Gti Diagnostics, Inc. | LCO | Class II | 2020-06-18 |
| K200909 | Hemo Control (optional Add Pack Hemo Control DM) | Ekf-Diagnostic GmbH | GKR | Class II | 2020-06-12 |
| K193124 | Unicel DxH 800 Coulter Cellular Analysis System | Beckman Coulter | GKZ | Class II | 2020-04-16 |
| K200204 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | GGZ | Class II | 2020-04-06 |
| K192987 | Aina HbA1c Monitoring System 2 | Jana Care, Inc. | LCP | Class II | 2020-03-26 |
| K193393 | BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). | Leica Biosystems Newcastle, Ltd. | MXZ | Class II | 2020-03-06 |
| K183680 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | JPI | Class II | 2020-02-28 |
| K191364 | 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 | Fujimori Kogyo, Co., Ltd. | JOZ | Class II | 2020-02-14 |
| K191147 | OC-Auto SENSOR io iFOB Test | Eiken Chemical Co., Ltd. | OOX | Class II | 2020-01-02 |
| K193041 | Hemochron Signature Elite | Accriva Diagnostics, Inc. | JPA | Class II | 2019-11-22 |
| K192842 | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High | Eurotrol B.V. | GGM | Class II | 2019-11-15 |
| K190898 | Sight OLO | Sight Diagnostics , Ltd. | GKZ | Class II | 2019-11-01 |
| K192369 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | Ixensor Co, Ltd. | LCP | Class II | 2019-10-29 |
| K182886 | Cytomics FC 500 Series (MPL or MCL) Flow Cytometer | Beckman Coulter | GKZ | Class II | 2019-09-06 |
| K183390 | QNext and DG-PT | Diagnostic Grifols, S.A. | JPA | Class II | 2019-08-21 |
| K183230 | OneDraw A1C Test System | Drawbridge Health, Inc. | LCP | Class II | 2019-08-15 |
| K183088 | ADVIA Centaur Erythropoietin (EPO) assay | Axis-Shield Diagnostics Limited | GGT | Class II | 2019-08-02 |
| K183602 | SwimCount Sperm Quality Test | Motilitycount Aps | POV | Class II | 2019-06-27 |
| K183160 | TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge | Haemonetics Corporation | JPA | Class II | 2019-05-09 |
| K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | Ixensor Co, Ltd. | LCP | Class II | 2019-04-12 |
| K181777 | AggreGuide A-100 ADP | Aggredyne, Inc. | JOZ | Class II | 2019-03-29 |
| K183592 | ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer | Beckman Coulter | PWD | Class II | 2019-03-21 |
| K190294 | CELL-DYN Emerald 22 AL System | Abbott Laboratories | GKZ | Class II | 2019-03-15 |
| K183440 | CRYOcheck FVIII Inhibitor Kit | Precision Biologic, Inc. | GGP | Class II | 2019-03-12 |
| DEN180017 | Quantra Hemostasis Analyzer, QPlus Cartridge | Hemosonics, LLC | QFR | Class II | 2019-03-12 |
| K181475 | DxH 520 Hematology Instrument | Beckman Coulter | GKZ | Class II | 2019-03-01 |
| K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | Coagusense, Inc. | GJS | Class II | 2019-02-21 |
| K180509 | Quo-Test A1c System | Ekf-Diagnostic GmbH | LCP | Class II | 2019-02-16 |
| K181751 | HemoCue Hb 801 System | Hemocue AB | GKR | Class II | 2019-02-01 |
| K182744 | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High | Eurotrol B.V. | GGM | Class II | 2019-02-01 |
| K182389 | Sysmex XN-L Automated Hematology Analyzer | Sysmex America, Inc. | GKZ | Class II | 2019-01-25 |
| K180780 | microINR System | Iline Microsystems, S.L. | GJS | Class II | 2019-01-25 |
| K180762 | CAPI 3 HEMOGLOBIN(E) | Sebia | GKA | Class II | 2018-12-14 |
| K183100 | Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra | Leica Biosystems Newcastle, Limited | MYA | Class II | 2018-12-07 |
| K183102 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody | Leica Biosystems Newcastle, Limited | MXZ | Class II | 2018-12-07 |
| K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | Bonraybio Co., Ltd. | POV | Class II | 2018-11-16 |
| K182298 | hemochroma PLUS System | Immunostics Inc., | GKR | Class II | 2018-11-16 |
| K181288 | Athelas One | Athelas, Inc. | GKZ | Class II | 2018-11-05 |
| K182062 | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device | Sysmex America, Inc. | JOY | Class II | 2018-10-30 |
| K180020 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies, Ltd. | GKZ | Class II | 2018-10-29 |
| K180209 | Diazyme 1,5-AG Assay | Diazyme Laboratories, Inc. | NOZ | Class II | 2018-10-04 |
| K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) System | Kawasumi Laboratories, Inc. | KSB | Class II | 2018-09-28 |
| K173127 | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) | Skyla Corporation H.S.P.B | LCP | Class II | 2018-09-25 |
| K181525 | INNOVANCE Free PS Ag | Siemens Healthcare Diagnostics Products GmbH | GGP | Class II | 2018-09-07 |
| K180186 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | GGZ | Class II | 2018-08-23 |
| K173202 | CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set | Sekisui Medical Co., Ltd. | JPA | Class II | 2018-05-09 |
| K171883 | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | Sysmex America, Inc. | LKM | Class II | 2018-04-23 |
| K180684 | CoaguChek XS Plus System | Roche Diagnostics | GJS | Class II | 2018-04-19 |
| K180693 | CoaguChek XS Pro System | Roche Diagnostics | GJS | Class II | 2018-04-19 |
| K172173 | DiaSpect Tm, DiaSpect Tm Cuvettes | Ekf-Diagnostic GmbH | GKR | Class II | 2018-04-06 |
| K180486 | HemosIL Factor XII Deficient Plasma | Instrumentation Laboratory CO | GJT | Class II | 2018-03-22 |
| K171655 | cobas m 511 integrated hematology analyzer | Roche Diagnostics Hematology, Inc. | GKZ | Class II | 2018-03-02 |
| K170623 | ACE Hemoglobin A1c (HbA1c) Reagent | Alfa Wassermann Diagnostic Technologies, LLC | LCP | Class II | 2018-02-27 |
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood Test | Alfa Scientific Designs, Inc. | KHE | Class II | 2018-02-15 |
| K172913 | cobas Factor II and Factor V Test | Roche Molecular Systems, Inc. | NPR | Class II | 2018-01-12 |
| K170960 | CoaguChek Vantus System | Roche Diagnostics | GJS | Class II | 2017-12-25 |
| K170005 | FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) | Dako Denmark A/S | MXZ | Class II | 2017-12-21 |
| K170028 | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) | Dako Denmark A/S | MYA | Class II | 2017-12-21 |
| K172286 | Automated Blood Coagulation Analyzer CS-2500 | Siemens Healthcare Diagnostic Products GmbH | JPA | Class II | 2017-12-18 |
| K172903 | HemosIL D-Dimer HS 500 | Instrumentation Laboratory CO | DAP | Class II | 2017-11-22 |
| K171650 | Alere Afinion HbA1c and ACR on Afinion 2 analyzer | Abbott Rapid Diagnostics | LCP | Class II | 2017-11-21 |
| K172514 | Trak Plus Male Fertility Testing System | Sandstone Diagnostics, Inc. | POV | Class II | 2017-11-17 |
| K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived Use | Sysmex America, Inc. | GKZ | Class II | 2017-11-06 |
| K170353 | ABX MICROS ES 60 OT and ABX MICROS ES 60 CT | HORIBA ABX SAS | GKZ | Class II | 2017-11-01 |
| K172333 | Sysmex CS-5100 | Siemens Healthcare Diagnostics Products GmbH | JPA | Class II | 2017-10-31 |
| K170147 | Lucica Glycated Albumin-L | Asahi Kasei Pharma Corporation | LCP | Class II | 2017-10-12 |
| K170548 | InSure ONE | Enterix, Inc. | KHE | Class II | 2017-10-05 |
| K163215 | AnemoCheck | Sanguina, LLC | KHG | Class II | 2017-09-13 |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software | Bio-Rad Laboratories, Inc. | GKA | Class II | 2017-09-13 |
| K170854 | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls | Instrumentation Laboratory CO | LCO | Class II | 2017-09-08 |
| K163465 | hemochroma PLUS System | Immunostics Inc., | GKR | Class II | 2017-09-08 |
| K163342 | i-STAT Hematocrit test with i-STAT Alinity System | Abbott Laboratories | JPI | Class II | 2017-08-22 |
| K162540 | INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls | Siemens Healthcare Diagnostics Prodcts GmbH | KFF | Class II | 2017-08-22 |
| K162977 | ADVIA 2120i, ADVIA 2120 | Siemens Healthcare Diagnostics | GKZ | Class II | 2017-08-11 |
| K163225 | AFIAS iFOB with AFIAS-50 | Immunostics Inc., | OOX | Class II | 2017-08-08 |
| K171315 | Advanced RBC Application | CellaVision AB | JOY | Class II | 2017-08-01 |
| K163633 | cobas HbA1c Test, cobas b 101 system | Roche Diagnostics Operations | LCP | Class II | 2017-07-28 |
| K171753 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 | Leica Biosystems Newcastle, Limited | MXZ | Class II | 2017-07-21 |
| K170974 | 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 | Becton, Dickinson and Company | OYE | Class II | 2017-07-03 |
| DEN160047 | ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M | Beckman Coulter | PWD | Class II | 2017-06-29 |
| K162897 | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser | Beckman Coulter | OYE | Class II | 2017-06-23 |
| K170864 | VALIDATE D-Dimer Calibration Verification / Linearity Test Kit | Maine Standards Company, LLC | GGN | Class II | 2017-06-21 |
| K161533 | A1C EZ Glycohemoglobin Analysis System | Biohermes Co., Ltd. | LCP | Class II | 2017-06-16 |
| K171484 | hema-screen SPECIFIC Gold | Immunostics Inc., | KHE | Class II | 2017-06-14 |
| K162333 | Wondfo One Step Fecal Occult Blood (FOB) Test | Guangzhou Wondfo Biotech Co., Ltd. | KHE | Class II | 2017-05-14 |
| K160502 | TEG 6s Hemostasis System | Haemonetics Corporation | JPA | Class II | 2017-04-19 |
| K163274 | AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument | Aggredyne, Inc. | JOZ | Class II | 2017-04-05 |
4,197 clearances in the Hematology panel. Data: openFDA.