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
2618 Hematology devices
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
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
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 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 15, 1993
STAGO FACTOR IX-DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
124d
Cleared
Nov 05, 1993
GLYCOHEMOGLOBIN
LCP
Assay, Glycosylated Hemoglobin
241d
Cleared
Nov 05, 1993
NEW STACHROM PROTEIN C TEST KIT
GGP
Test, Qualitative And Quantitative Factor Deficiency
206d
Cleared
Nov 03, 1993
FDP - SLIDEX DIRECT
GHH
Fibrin Split Products
554d
Cleared
Nov 03, 1993
CA-1000 AUTOMATED COAGULATION ANALYZER
JPA
System, Multipurpose For In Vitro Coagulation Studies
240d
Cleared
Nov 02, 1993
AGGRO/LINK CONTROL SOFTWARE
JBX
Aggregrometer, Platelet
159d
Cleared
Nov 02, 1993
FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
153d
Cleared
Oct 27, 1993
STAGO FACTOR XII-DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
105d
Cleared
Oct 27, 1993
STAGO FACTOR VII-DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
105d
Cleared
Oct 27, 1993
STAGO FACTOR X-DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
105d
Cleared
Oct 27, 1993
STAGO FACTOR XI-DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
105d
Cleared
Oct 25, 1993
PATHROMTIN
GFO
Activated Partial Thromboplastin
185d
Cleared
Oct 18, 1993
COAGULATION REFERENCE PLASMA, NORMAL
GIZ
Plasma, Control, Normal
167d
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