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
Dec 24, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
JBQ
Antithrombin Iii Quantitation
54d
Cleared
Nov 24, 1997
SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT
LCP
Assay, Glycosylated Hemoglobin
59d
Cleared
Nov 04, 1997
IL TEST D-DIMER
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
109d
Cleared
Nov 04, 1997
IL TEST APTT-SP
GFO
Activated Partial Thromboplastin
62d
Cleared
Sep 16, 1997
ABBOTT CELL-DYN 3200 SYSTEM
GKZ
Counter, Differential Cell
84d
Cleared
Aug 12, 1997
ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)
GKZ
Counter, Differential Cell
137d
Cleared
Aug 06, 1997
VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
LCQ
Fluorescent Immunoassay Gentamicin
26d
Cleared
Apr 22, 1997
COAGUCHEK PST SYSTEM
GJS
Test, Time, Prothrombin
295d
Cleared
Feb 20, 1997
LYPHOCHEK COAGULATION CONTROL
GGN
Plasma, Coagulation Control
71d
Cleared
Dec 10, 1996
THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451
JPA
System, Multipurpose For In Vitro Coagulation Studies
208d
Cleared
Oct 08, 1996
CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
GKZ
Counter, Differential Cell
313d
Cleared
Sep 04, 1996
ACL 6000 SYSTEM (ACL 6000)
GKP
Instrument, Coagulation, Automated
106d
Cleared
Jun 26, 1996
THERMACYL BLOOD/FLUID WARMER
BSB
Warmer, Blood, Non-electromagnetic Radiation
321d
Cleared
May 20, 1996
CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
GKZ
Counter, Differential Cell
196d
Cleared
Apr 26, 1996
VARIANT ALPHA-THALASSEMIA SHORT PROGRAM
GKA
Abnormal Hemoglobin Quantitation
157d
Cleared
Mar 11, 1996
PORCINE FACTOR VIII
GGN
Plasma, Coagulation Control
298d
Cleared
Feb 14, 1996
CHROM Z-HEPARIN, CAT. NO 5242
KFF
Assay, Heparin
247d
Cleared
Feb 09, 1996
ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P
LCP
Assay, Glycosylated Hemoglobin
266d
Cleared
Feb 09, 1996
CHROM Z-F:VIII, CAT. NO. 5241
GGP
Test, Qualitative And Quantitative Factor Deficiency
242d
Cleared
Jan 30, 1996
CHROM Z-PROTEIN C, CAT. NO. 5243
GGP
Test, Qualitative And Quantitative Factor Deficiency
232d
Cleared
Dec 07, 1995
CHROM Z-PLASMINOGEN, CAT. NO. 5244
GGP
Test, Qualitative And Quantitative Factor Deficiency
178d
Cleared
Nov 21, 1995
COAGUCHEK SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
166d
Cleared
Nov 20, 1995
VARIANT HEMOGLOBINOPATHY PROGRAM
GKA
Abnormal Hemoglobin Quantitation
84d
Cleared
Nov 13, 1995
CHROM Z CHROMOGENIC ASSAYS
JBQ
Antithrombin Iii Quantitation
201d
Cleared
Nov 03, 1995
ACL FUTURA COAGULATION SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
193d
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