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
Mar 07, 1994
FACTOR VII DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
137d
Cleared
Mar 07, 1994
FACTOR
GJT
Plasma, Coagulation Factor Deficient
137d
Cleared
Mar 01, 1994
STAGO FACTOR V-DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
155d
Cleared
Mar 01, 1994
STAGO FACTOR II-DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
155d
Cleared
Feb 23, 1994
TINTELIZER(R) TPA
GGP
Test, Qualitative And Quantitative Factor Deficiency
175d
Cleared
Feb 22, 1994
PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)
GGC
Control, Plasma, Abnormal
540d
Cleared
Feb 22, 1994
CONTROL PLASMA U
GGC
Control, Plasma, Abnormal
540d
Cleared
Feb 22, 1994
CONTROL PLASMA N
GIZ
Plasma, Control, Normal
540d
Cleared
Feb 07, 1994
IL TEST HEPARIN (XA), PN 84699-15
KFF
Assay, Heparin
101d
Cleared
Feb 03, 1994
FAST'N'FLAMMATORY KIT
GIA
Test, Leukocyte Peroxidase
329d
Cleared
Jan 27, 1994
HEMOCARD, HEMOGLOBIN C ASSAY
MLL
Hemoglobin C (abnormal Hemoglobin Variant)
577d
Cleared
Jan 27, 1994
SPECTROLYSE HEPARIN KIT
KFF
Assay, Heparin
561d
Cleared
Jan 27, 1994
MDA PROTEIN ASSAY
GGP
Test, Qualitative And Quantitative Factor Deficiency
447d
Cleared
Jan 27, 1994
TOA MEDICAL ELECTRONICS CA-5000
JPA
System, Multipurpose For In Vitro Coagulation Studies
170d
Cleared
Jan 27, 1994
CENTRIFIQ BLOOD CONTROL
JPK
Mixture, Hematology Quality Control
128d
Cleared
Dec 27, 1993
PARA 4 PLUS
JJY
Multi-analyte Controls, All Kinds (assayed)
143d
Cleared
Dec 06, 1993
REFLOTRON HEMOGLOBIN TEST TABS
KHG
Whole Blood Hemoglobin Determination
159d
Cleared
Dec 06, 1993
APTT-ES REAGENT
GFO
Activated Partial Thromboplastin
90d
Cleared
Dec 06, 1993
CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE
JCN
Control, Cell Counter, Normal And Abnormal
83d
Cleared
Dec 06, 1993
SPECTROLYSE FACTOR VII:C
GGP
Test, Qualitative And Quantitative Factor Deficiency
74d
Cleared
Dec 03, 1993
R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470
JPA
System, Multipurpose For In Vitro Coagulation Studies
60d
Cleared
Nov 29, 1993
BATROXOBIN REAGENT
JCO
Bothrops Atrox Reagent
173d
Cleared
Nov 22, 1993
TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11
GKZ
Counter, Differential Cell
129d
Cleared
Nov 22, 1993
TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11
GKZ
Counter, Differential Cell
129d
Cleared
Nov 15, 1993
TAS ANALYZER
GKP
Instrument, Coagulation, Automated
144d
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