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 19, 1987
DR.BRUNO LANGE MINI-HBA1 PHOTOMETER
GKR
System, Hemoglobin, Automated
85d
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
Mar 16, 1987
CHART-TYPE MICRO HEMATOCRIT TUBE READER
JPI
Device, Hematocrit Measuring
39d
Cleared
Feb 24, 1987
N-D URINE TUBE SYSTEM (N-D TUBE/CAP/PIPETTE)
JXA
Kit, Screening, Urine
123d
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
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 09, 1986
HEMOCCULT WIPE TEST
KHE
Reagent, Occult Blood
133d
Cleared
Dec 04, 1986
IL TEST 97573-15, PLASMINOGEN ASSAY
DDX
Plasminogen, Antigen, Antiserum, Control
37d
Cleared
Dec 04, 1986
SIMPLASTIN EXCEL
GJS
Test, Time, Prothrombin
35d
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
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