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
778 Hematology devices
Cleared
Oct 31, 1991
MONOCLONAL ANTIBODY ANTI-CD3
GKZ
Counter, Differential Cell
597d
Cleared
Oct 18, 1991
QBC E-Z PREP
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
80d
Cleared
Oct 09, 1991
IL TEST PROCLOT ASSAY STYSTEM
GGP
Test, Qualitative And Quantitative Factor Deficiency
112d
Cleared
Sep 27, 1991
ROCHE COBAS ARGOS 5 DIFF
GZI
Stimulator, Neuromuscular, External Functional
106d
Cleared
Sep 23, 1991
BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT
LCP
Assay, Glycosylated Hemoglobin
276d
Cleared
Sep 19, 1991
ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS
JPA
System, Multipurpose For In Vitro Coagulation Studies
129d
Cleared
Sep 10, 1991
DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN)
GJT
Plasma, Coagulation Factor Deficient
84d
Cleared
Aug 22, 1991
ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED
GGN
Plasma, Coagulation Control
142d
Cleared
Aug 22, 1991
ARACHIDONIC ACID
JBX
Aggregrometer, Platelet
59d
Cleared
Aug 16, 1991
PACKS-4 (TM) ANALYZER
JBY
Aggregometer, Platelet, Photo-optical Scanning
88d
Cleared
Jul 03, 1991
COLOCARE
KHE
Reagent, Occult Blood
226d
Cleared
Jul 03, 1991
COLOSCREEN
KHE
Reagent, Occult Blood
114d
Cleared
Jun 11, 1991
DADE(R) PROTEIN C ABNORMAL CONTRAL
GGC
Control, Plasma, Abnormal
43d
Cleared
Jun 10, 1991
LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL
JCM
Control, Hemoglobin, Abnormal
75d
Cleared
May 20, 1991
EPINEPHRINE REAGENT, CAT. NO. 5367
GHR
Reagent, Platelet Aggregation
94d
Cleared
May 20, 1991
COLLAGEN REAGENT CAT. NO. 5368
GHR
Reagent, Platelet Aggregation
89d
Cleared
May 20, 1991
ADP REAGENT
GHR
Reagent, Platelet Aggregation
84d
Cleared
May 07, 1991
QBC AUTOREADER
GKZ
Counter, Differential Cell
69d
Cleared
Apr 16, 1991
HELENA THROMBOPLASTIN REAGENT WITH DILUENT
GJS
Test, Time, Prothrombin
110d
Cleared
Feb 27, 1991
HELENA THROMBOPLASTIN REAGENT, MODIFICATION
GJS
Test, Time, Prothrombin
75d
Cleared
Feb 26, 1991
DADE PROTEIN C CLOTTING ASSAY
GGP
Test, Qualitative And Quantitative Factor Deficiency
209d
Cleared
Feb 11, 1991
AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183
GGN
Plasma, Coagulation Control
55d
Cleared
Feb 07, 1991
ABBOTT VISION(TM) GLYCATED HB
LCP
Assay, Glycosylated Hemoglobin
161d
Cleared
Jan 18, 1991
FREE PROTEIN S REAGENT CAT. NO. 5363
GGP
Test, Qualitative And Quantitative Factor Deficiency
126d
Cleared
Dec 31, 1990
FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM
GKH
Apparatus, Automated Blood Cell Diluting
73d
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