FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Hematology ×
3,294 results
1369–1392 of 3,294
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Oct 31, 1994
AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328
K933086 · JCM
Helena Laboratories
Hematology · 495d
Cleared Oct 27, 1994
GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION
K925909 · GKZ
Alicia Diagnostics, Inc.
Hematology · 723d
Cleared Oct 18, 1994
HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM
K940957 · JPA
International Technidyne Corp.
Hematology · 231d
Cleared Oct 13, 1994
AGGRO/LINK VW COFACTOR SOFTWARE
K940792 · JOZ
Chrono-Log Corp.
Hematology · 233d
Cleared Oct 11, 1994
TINA-QUANT HEMOGLOBIN A1C
K934070 · LCP
Boehringer Mannheim Corp.
Hematology · 417d
Cleared Oct 07, 1994
SPECIALTY ASSAYED CONTROL-1
K941737 · GIZ
Helena Laboratories
Hematology · 183d
Cleared Oct 07, 1994
CBC-LINE HEMATOLOGY LINEARITY CONTROL
K942822 · JPK
R&D Systems, Inc.
Hematology · 114d
Cleared Sep 30, 1994
AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS
K925274 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 711d
Cleared Sep 20, 1994
MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER
K940426 · GKN
Medtronic Hemotec, Inc.
Hematology · 232d
Cleared Sep 20, 1994
AURATEK FDP
K943787 · DAP
Organon Teknika Corp.
Hematology · 48d
Cleared Sep 19, 1994
DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA
K935254 · GIZ
American Diagnostica, Inc.
Hematology · 322d
Cleared Sep 14, 1994
SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)
K941860 · GGN
Helena Laboratories
Hematology · 152d
Cleared Sep 14, 1994
PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY
K942009 · LCP
Primus Corp.
Hematology · 142d
Cleared Sep 09, 1994
FASCOUNT SYSTME
K933486 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 417d
Cleared Sep 08, 1994
LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2
K934741 · GIL
Clinical Controls, Inc.
Hematology · 342d
Cleared Aug 30, 1994
SEMEN ANALYSIS KIT
K915229 · POV
Humagen Fertility Diagnostics, Inc.
Hematology · 1014d
Cleared Aug 30, 1994
ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT
K941001 · GIS
Diagnostic Specialties
Hematology · 182d
Cleared Jul 19, 1994
QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
K936016 · GGT
R&D Systems, Inc.
Hematology · 215d
Cleared Jul 19, 1994
ACT CONTROL SET
K940840 · JPA
Sigma Diagnostics, Inc.
Hematology · 146d
Cleared Jul 19, 1994
AMES DCA 2000 HEMOGLOBIN ALC CONTROLS
K940971 · LCP
Heraeus Kulzer, Inc.
Hematology · 139d
Cleared Jun 30, 1994
CATALOG NO. J-ACT+ & QC-ACT+
K941007 · JBP
International Technidyne Corp.
Hematology · 121d
Cleared Jun 16, 1994
LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH
K942209 · JCN
Bio-Rad
Hematology · 42d
Cleared Jun 06, 1994
CD-CHEX CD4 LOW
K931825 · GGL
Streck Laboratories, Inc.
Hematology · 426d
Cleared May 18, 1994
MICROCOAGULATION PROTHROMBIN TIME TEST
K940432 · GJS
International Technidyne Corp.
Hematology · 107d