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.
3293
Total
3286
Cleared
158d
Avg (2y)
1976
Since
1855 Hematology devices
Cleared
Aug 09, 1993
STACLOT(R) PNP TEST KIT
GGW
Test, Time, Partial Thromboplastin
346d
Cleared
Aug 09, 1993
TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II
LGS
Fluorescence Polarization Immunoassay, Theophylline
98d
Cleared
Aug 05, 1993
BOEHRINGER MANNHEIM COAGUCHEK SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
190d
Cleared
Jul 20, 1993
QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY
GGT
Assay, Erythropoietin
105d
Cleared
Jul 14, 1993
ABBOTT ENCOUNTER(TM)Q
GKZ
Counter, Differential Cell
174d
Cleared
Jul 06, 1993
CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON
GKZ
Counter, Differential Cell
214d
Cleared
Jul 06, 1993
REP ALKALINE HB-15 #3196,-8 #3197,-4 3198
JBD
System, Analysis, Electrophoretic Hemoglobin
104d
Cleared
Jun 28, 1993
BERICHROM HEPARIN
KFF
Assay, Heparin
255d
Cleared
Jun 22, 1993
TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)
GKL
Counter, Cell, Automated (particle Counter)
132d
Cleared
Jun 18, 1993
IL MCL-2 COAGULATION ANALYZER
GKP
Instrument, Coagulation, Automated
309d
Cleared
Jun 18, 1993
CHECKPOINT
JPK
Mixture, Hematology Quality Control
60d
Cleared
Jun 08, 1993
CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
281d
Cleared
Jun 02, 1993
VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY
GGJ
Fluid, Diluting, White-cell
161d
Cleared
May 21, 1993
CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
263d
Cleared
May 20, 1993
FACTOR CONTROL [P]
GGC
Control, Plasma, Abnormal
85d
Cleared
May 18, 1993
BIOMERIEUX HEMOLAB FIBRINOMAT
GIS
Test, Fibrinogen
197d
Cleared
May 14, 1993
TEST THROMBIN
GJA
Test, Thrombin Time
121d
Cleared
May 11, 1993
TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)
GKZ
Counter, Differential Cell
119d
Cleared
May 11, 1993
THROMBOPLATIN-M WITH CALCIUM
GJS
Test, Time, Prothrombin
116d
Cleared
Apr 27, 1993
ACS APCT REAGENT, MODIFIED
GFO
Activated Partial Thromboplastin
158d
Cleared
Apr 27, 1993
COAG-CONTROL
GGC
Control, Plasma, Abnormal
63d
Cleared
Apr 20, 1993
VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA
JPA
System, Multipurpose For In Vitro Coagulation Studies
61d
Cleared
Apr 12, 1993
IL TEST(TM) PROTEIN S
GGP
Test, Qualitative And Quantitative Factor Deficiency
80d
Cleared
Apr 08, 1993
HEMOCARD HEMOGLOBIN E
CKA
Nadh Oxidation/nad Reduction, Alt/sgpt
92d
Cleared
Apr 05, 1993
COULTER RETIC-C CELL CONTROL
JPK
Mixture, Hematology Quality Control
83d
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