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
2620 Hematology devices
Cleared
May 20, 1987
S-CAL HEMATOLOGY CALIBRATOR
KRY
Calibrator For Platelet Counting
351d
Cleared
Apr 28, 1987
GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT
LCP
Assay, Glycosylated Hemoglobin
153d
Cleared
Apr 23, 1987
PROTEIN S CONTROL PLASMA
GGP
Test, Qualitative And Quantitative Factor Deficiency
48d
Cleared
Apr 20, 1987
PROTHROMBIN TIME TEST
GJS
Test, Time, Prothrombin
69d
Cleared
Apr 20, 1987
COAGULATION CONTROL, LEVEL I
JPA
System, Multipurpose For In Vitro Coagulation Studies
60d
Cleared
Apr 20, 1987
COAGULATION CONTROL, LEVEL II
JPA
System, Multipurpose For In Vitro Coagulation Studies
60d
Cleared
Apr 20, 1987
COAGULATION CONTROL, LEVEL III
JPA
System, Multipurpose For In Vitro Coagulation Studies
60d
Cleared
Apr 15, 1987
CYANMETHEMOGLOBIN STANDARD
KRZ
Calibrator For Hemoglobin And Hematocrit Measurement
15d
Cleared
Mar 31, 1987
O.O2 M CALCIUM CHLORIDE SOLUTION
JPA
System, Multipurpose For In Vitro Coagulation Studies
40d
Cleared
Mar 31, 1987
HL-1 SUPPLEMENT
KIT
Media And Components, Synthetic Cell And Tissue Culture
28d
Cleared
Mar 25, 1987
MSI HEMATOLOGY CONTROL +
JPK
Mixture, Hematology Quality Control
7d
Cleared
Mar 23, 1987
WINPETTE
JPH
Test, Erythrocyte Sedimentation Rate
5d
Cleared
Mar 17, 1987
CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER
GKZ
Counter, Differential Cell
55d
Cleared
Mar 17, 1987
COAG-A-MATE(R) XC
JPA
System, Multipurpose For In Vitro Coagulation Studies
7d
Cleared
Mar 16, 1987
HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD
KHG
Whole Blood Hemoglobin Determination
47d
Cleared
Feb 13, 1987
ASSERA-PLATE PROTEIN S KIT
39d
Cleared
Feb 10, 1987
IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN)
GGP
Test, Qualitative And Quantitative Factor Deficiency
12d
Cleared
Feb 10, 1987
IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)
GGP
Test, Qualitative And Quantitative Factor Deficiency
12d
Cleared
Feb 06, 1987
ELECTRA(R) 700 AUTOMATIC COAGULATION TIMER
JPA
System, Multipurpose For In Vitro Coagulation Studies
81d
Cleared
Feb 06, 1987
ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER
JPA
System, Multipurpose For In Vitro Coagulation Studies
81d
Cleared
Feb 06, 1987
H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS
KSA
Calibrator For Red-cell And White-cell Counting
70d
Cleared
Feb 04, 1987
IMMUNO-SURE
72d
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
PROTIME AUTOMATE TEST KIT
GJS
Test, Time, Prothrombin
60d
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