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.
3294
Total
3287
Cleared
164d
Avg (2y)
1976
Since
2617 Hematology devices
Cleared
Nov 17, 1997
DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/
JOZ
System, Automated Platelet Aggregation
280d
Cleared
Nov 07, 1997
MICRO21 WITH WBC ESTIMATE
JOY
Device, Automated Cell-locating
84d
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
Oct 31, 1997
ACCUCOLOR HIGH CALIBRATOR (A3089)
GIZ
Plasma, Control, Normal
59d
Cleared
Oct 29, 1997
COULTER AC.T DIFF ANALYZER
GKZ
Counter, Differential Cell
35d
Cleared
Oct 22, 1997
TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES
GKZ
Counter, Differential Cell
236d
Cleared
Oct 20, 1997
N-ASSAY TIA PLASMINOGEN TEST KIT
GGP
Test, Qualitative And Quantitative Factor Deficiency
144d
Cleared
Oct 20, 1997
N-ASSAY TIA ANTITHROMBIN III TEST KIT
DDQ
Antigen, Antiserum, Control, Antithrombin Iii
125d
Cleared
Oct 20, 1997
CS-400 COAGULATION ANALYZER SYSTEM (A1208)
JPA
System, Multipurpose For In Vitro Coagulation Studies
125d
Cleared
Oct 20, 1997
HEMAPROMPT
KHE
Reagent, Occult Blood
88d
Cleared
Oct 10, 1997
SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM
GJS
Test, Time, Prothrombin
74d
Cleared
Oct 09, 1997
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
KQJ
System, Fibrinogen Determination
142d
Cleared
Oct 06, 1997
REAADS PROTEIN C ANTIGEN TEST KIT
GGP
Test, Qualitative And Quantitative Factor Deficiency
104d
Cleared
Oct 01, 1997
B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN)
JBP
Activated Whole Blood Clotting Time
127d
Cleared
Sep 25, 1997
AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER
JWO
Device, Blood Volume Measuring
325d
Cleared
Sep 25, 1997
A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER
LCP
Assay, Glycosylated Hemoglobin
100d
Cleared
Sep 25, 1997
UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA
GGP
Test, Qualitative And Quantitative Factor Deficiency
34d
Cleared
Sep 22, 1997
QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM
GIO
Tube, Collection, Capillary Blood
42d
Cleared
Sep 16, 1997
MICRO21 WITH CEREBROSPINAL FLUID
JOY
Device, Automated Cell-locating
147d
Cleared
Sep 16, 1997
ABBOTT CELL-DYN 3200 SYSTEM
GKZ
Counter, Differential Cell
84d
Cleared
Sep 09, 1997
OPUS D-DIMER
GHH
Fibrin Split Products
81d
Cleared
Sep 05, 1997
EZCHEK/HBA BLOOD COLLECTION KIT
LCP
Assay, Glycosylated Hemoglobin
105d
Cleared
Aug 29, 1997
CRYO CHECK INR VALIDATION SET
GGN
Plasma, Coagulation Control
149d
Cleared
Aug 29, 1997
ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
GKL
Counter, Cell, Automated (particle Counter)
91d
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