FDA 510(k) Hematology Devices
FDA 510(k) Hematology Devices - Regulatory Overview
FDA 510(k) hematology devices include automated instruments used to analyze blood composition and coagulation. The FDA review panel code is HE.
Key device categories:
- Complete blood count (CBC) analyzers - automated cell counters for RBC, WBC and platelets
- Coagulation analyzers - PT/INR, aPTT, fibrinogen and factor assays
- Flow cytometry systems - immunophenotyping and cell sorting
- Blood typing and cross-match systems - transfusion medicine instruments
Most hematology devices are classified as Class II under 21 CFR Part 864. Data sourced from FDA 510(k) public files. Updated monthly.
3292
Total
3285
Cleared
161d
Avg (2y)
1976
Since
773 Hematology devices
Cleared
Jul 20, 2001
SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500
JPA
System, Multipurpose For In Vitro Coagulation Studies
88d
Cleared
Jul 10, 2001
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
LCP
Assay, Glycosylated Hemoglobin
119d
Cleared
Jul 09, 2001
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
GKZ
Counter, Differential Cell
68d
Cleared
Jun 25, 2001
IL TEST PROS
GGP
Test, Qualitative And Quantitative Factor Deficiency
47d
Cleared
Jun 21, 2001
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
JOZ
System, Automated Platelet Aggregation
279d
Cleared
Jun 06, 2001
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
GKZ
Counter, Differential Cell
68d
Cleared
May 29, 2001
TINA-QUANT D-DIMER TEST SYSTEM
GHH
Fibrin Split Products
46d
Cleared
May 01, 2001
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
JPA
System, Multipurpose For In Vitro Coagulation Studies
70d
Cleared
Apr 13, 2001
IL TEST FREE PROTEIN S
GGP
Test, Qualitative And Quantitative Factor Deficiency
64d
Cleared
Apr 13, 2001
COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
GKZ
Counter, Differential Cell
30d
Cleared
Mar 16, 2001
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
198d
Cleared
Feb 20, 2001
THROMBOREL S
GJS
Test, Time, Prothrombin
67d
Cleared
Feb 07, 2001
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
JPK
Mixture, Hematology Quality Control
30d
Cleared
Feb 07, 2001
5C-ES CELL CONTROL, MODELS 7547191, 7547192
JPK
Mixture, Hematology Quality Control
30d
Cleared
Dec 19, 2000
VARIANT II TOTAL GHB
LCP
Assay, Glycosylated Hemoglobin
61d
Cleared
Dec 18, 2000
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
LCP
Assay, Glycosylated Hemoglobin
74d
Cleared
Nov 29, 2000
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
GGM
Control, Hemoglobin
62d
Cleared
Nov 27, 2000
COLOSCREEN-ES
KHE
Reagent, Occult Blood
31d
Cleared
Nov 16, 2000
BEHRING COAGULATION SYSTEM, MODEL BCS
JPA
System, Multipurpose For In Vitro Coagulation Studies
129d
Cleared
Oct 13, 2000
COALIZA PROTEIN S-FREE
GGP
Test, Qualitative And Quantitative Factor Deficiency
63d
Cleared
Sep 26, 2000
PROTEIN C REAGENT
GGP
Test, Qualitative And Quantitative Factor Deficiency
41d
Cleared
Sep 06, 2000
COAGUCHEK S SYSTEM, MODEL 2138280
JPA
System, Multipurpose For In Vitro Coagulation Studies
258d
Cleared
Aug 30, 2000
MODIFICATION OF ACL ADVANCE
JPA
System, Multipurpose For In Vitro Coagulation Studies
26d
Cleared
Aug 04, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
GKP
Instrument, Coagulation, Automated
66d
Cleared
Jun 23, 2000
IL TEST LIQUID ANTITHROMBIN
JBQ
Antithrombin Iii Quantitation
190d
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