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
Feb 18, 2000
PACIFIC HEMOSTASIS THROMBOPLASTIN D
GJS
Test, Time, Prothrombin
77d
Cleared
Feb 16, 2000
GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05
GGC
Control, Plasma, Abnormal
135d
Cleared
Feb 15, 2000
HMP CONTROLS (TAS) RAPIDPOINT
GGN
Plasma, Coagulation Control
68d
Cleared
Feb 10, 2000
I-STAT SYSTEM
JBP
Activated Whole Blood Clotting Time
192d
Cleared
Feb 03, 2000
AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)
GJS
Test, Time, Prothrombin
71d
Cleared
Feb 01, 2000
GTI-FVIII INHIBITOR ASSAY
GGP
Test, Qualitative And Quantitative Factor Deficiency
104d
Cleared
Jan 28, 2000
ADVANCED D-DIMER
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
148d
Cleared
Jan 14, 2000
ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
JBP
Activated Whole Blood Clotting Time
143d
Cleared
Jan 14, 2000
RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
JOX
Analyzer, Heparin, Automated
88d
Cleared
Jan 14, 2000
HEMOSITE TEST SYSTEM
KHG
Whole Blood Hemoglobin Determination
43d
Cleared
Jan 14, 2000
XE CHECK
GLQ
Mixture, Control, White-cell And Red-cell Indices
17d
Cleared
Jan 11, 2000
BEHRING COAGULATION SYSTEM (BCS)
JPA
System, Multipurpose For In Vitro Coagulation Studies
131d
Cleared
Dec 21, 1999
HEMOCHEK-A1C SAMPLE COLLECTION KIT
LCP
Assay, Glycosylated Hemoglobin
278d
Cleared
Dec 21, 1999
GRADILEIDEN V TEST
GGW
Test, Time, Partial Thromboplastin
151d
Cleared
Dec 21, 1999
PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2
LCP
Assay, Glycosylated Hemoglobin
22d
Cleared
Dec 20, 1999
POLLER CALIBRANTS
GGN
Plasma, Coagulation Control
238d
Cleared
Dec 20, 1999
ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM
JOZ
System, Automated Platelet Aggregation
145d
Cleared
Dec 20, 1999
CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER
KRX
Calibrator For Cell Indices
74d
Cleared
Dec 14, 1999
SIMPLIFY D-DIMER, MODEL DCGK1
GHH
Fibrin Split Products
75d
Cleared
Dec 07, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
GKP
Instrument, Coagulation, Automated
67d
Cleared
Dec 06, 1999
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
GFO
Activated Partial Thromboplastin
117d
Cleared
Dec 06, 1999
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
GFO
Activated Partial Thromboplastin
117d
Cleared
Dec 06, 1999
COLON ALERT TEST
KHE
Reagent, Occult Blood
111d
Cleared
Dec 06, 1999
K-ASSAY FIBRINOGEN
GIS
Test, Fibrinogen
53d
Cleared
Dec 02, 1999
STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR
GLY
Oximeter To Measure Hemoglobin
77d
Looking for a specific hematology device? Search by device name, K-number or manufacturer.
Search all Hematology 510(k) devices