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.
3297
Total
3290
Cleared
164d
Avg (2y)
1976
Since
3297 Hematology devices
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
May 07, 1993
CRIT-LINE
JPI
Device, Hematocrit Measuring
261d
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 06, 1993
LUCOR CONFIRMATORY REAGENT
GIR
Reagent, Russel Viper Venom
334d
Cleared
Apr 06, 1993
LUPO-TEST REGEANT
GIR
Reagent, Russel Viper Venom
330d
Cleared
Apr 05, 1993
COULTER RETIC-C CELL CONTROL
JPK
Mixture, Hematology Quality Control
83d
Cleared
Mar 29, 1993
VARIANT(TM) HEMOGLOBIN A 1C PROGRAM
LCP
Assay, Glycosylated Hemoglobin
91d
Cleared
Mar 23, 1993
COAGULATION CONTROL CONTAINING HEMOGLOBIN
JPA
System, Multipurpose For In Vitro Coagulation Studies
154d
Cleared
Mar 23, 1993
MICROHEMATOCRIT ROTOR
GKG
Centrifuge, Hematocrit
56d
Cleared
Mar 12, 1993
ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT
GJS
Test, Time, Prothrombin
127d
Cleared
Mar 11, 1993
VARIANT BETA-THALASSEMIA SHORT PROGRAM
JPD
Hemoglobin A2 Quantitation
209d
Cleared
Mar 09, 1993
FIBRINOGEN RID TEST KIT
KQJ
System, Fibrinogen Determination
292d
Cleared
Mar 01, 1993
QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
133d
Cleared
Mar 01, 1993
MULTIFIBREN
KQJ
System, Fibrinogen Determination
96d
Cleared
Feb 25, 1993
CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM
GGN
Plasma, Coagulation Control
254d
Cleared
Feb 12, 1993
NYCOPLASTIN
GJS
Test, Time, Prothrombin
359d
Cleared
Feb 12, 1993
OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376
JPA
System, Multipurpose For In Vitro Coagulation Studies
64d
Cleared
Feb 05, 1993
CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1
GKZ
Counter, Differential Cell
242d
Cleared
Feb 05, 1993
CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1
GKZ
Counter, Differential Cell
242d
Cleared
Feb 05, 1993
CELLEXIS HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
196d
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