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
Sep 30, 1987
FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT
GKL
Counter, Cell, Automated (particle Counter)
117d
Cleared
Sep 15, 1987
MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE
DBT
Factor Xiii A, S, Antigen, Antiserum, Control
98d
Cleared
Jul 23, 1987
EASY-TEST HEMOGLOBIN (HGB) ITEM #16685
KHG
Whole Blood Hemoglobin Determination
16d
Cleared
Jul 09, 1987
CHROM-TROL
JPA
System, Multipurpose For In Vitro Coagulation Studies
20d
Cleared
Jul 06, 1987
MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER
LCP
Assay, Glycosylated Hemoglobin
90d
Cleared
Jun 10, 1987
Q.I.C. BLEEDING TIME DEVICE
JCA
Device, Bleeding Time
68d
Cleared
Jan 21, 1987
IL TEST 84668-15, FACTOR VIII CONTROL PLASMA
GGP
Test, Qualitative And Quantitative Factor Deficiency
69d
Cleared
Jan 05, 1987
IL TEST 97575-15, HEPARIN ASSAY
KFF
Assay, Heparin
69d
Cleared
Jan 05, 1987
COAGULATION INTRINSIC DEFICIENT PLASMAS
GGP
Test, Qualitative And Quantitative Factor Deficiency
53d
Cleared
Jan 05, 1987
COAGULATION EXTRINSIC DEFICIENT PLASMAS
GGP
Test, Qualitative And Quantitative Factor Deficiency
52d
Cleared
Jan 05, 1987
SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE
GKF
Instrument, Hematocrit, Automated
41d
Cleared
Dec 04, 1986
IL TEST 97573-15, PLASMINOGEN ASSAY
DDX
Plasminogen, Antigen, Antiserum, Control
37d
Cleared
Nov 25, 1986
IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY
LGP
Assay, Alpha-2-antiplasmin
28d
Cleared
Nov 25, 1986
IL TEST 97574-15M, ANTITTHROMBIN III ASSASY
JBQ
Antithrombin Iii Quantitation
28d
Cleared
Nov 25, 1986
IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA
JPA
System, Multipurpose For In Vitro Coagulation Studies
27d
Cleared
Sep 16, 1986
HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)
LCP
Assay, Glycosylated Hemoglobin
84d
Cleared
Sep 04, 1986
CELLECT 8E AUTOMATED BLOOD CELL COUNTERS
GKL
Counter, Cell, Automated (particle Counter)
72d
Cleared
Sep 04, 1986
IL CELLECT 7
GKL
Counter, Cell, Automated (particle Counter)
10d
Cleared
Sep 04, 1986
IL CELLECT 8
GKL
Counter, Cell, Automated (particle Counter)
10d
Cleared
Sep 03, 1986
IL SYSTEM 810, ACL AND THE REAGENT SETS
GJA
Test, Thrombin Time
78d
Cleared
Aug 18, 1986
VISION(TM) HEMOGLOBIN
KHG
Whole Blood Hemoglobin Determination
69d
Cleared
Jul 02, 1986
ANTI-LEU-12 B CELL REAGENT
LJD
Assay, B Lymphocyte Marker
439d
Cleared
Jul 01, 1986
LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II
JPK
Mixture, Hematology Quality Control
22d
Cleared
May 29, 1986
PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765
GGP
Test, Qualitative And Quantitative Factor Deficiency
71d
Cleared
May 29, 1986
HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA
GGP
Test, Qualitative And Quantitative Factor Deficiency
71d
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