Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Hematology ×
3,297 results
1249–1272 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Nov 20, 1995
VARIANT HEMOGLOBINOPATHY PROGRAM
K954048 · GKA
Bio-Rad
Hematology · 84d
Cleared Nov 14, 1995
ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT
K933878 · GKZ
Intracel Corp.
Hematology · 827d
Cleared Nov 13, 1995
CHROM Z CHROMOGENIC ASSAYS
K951943 · JBQ
Helena Laboratories
Hematology · 201d
Cleared Nov 13, 1995
ASSERACHROM FREE PROTEIN S KIT
K954017 · GGP
American Bioproducts Co.
Hematology · 80d
Cleared Nov 13, 1995
ASSERACHROM TOTAL PROTEIN S KIT
K954040 · GGP
American Bioproducts Co.
Hematology · 77d
Cleared Nov 06, 1995
COAMATIC FACTOR VIII
K943225 · GGP
Pharmacia Hepar, Inc.
Hematology · 488d
Cleared Nov 06, 1995
CRYO CHECK LUPUS PLASMA
K952623 · GGC
Precision Biologicals, Inc.
Hematology · 151d
Cleared Nov 03, 1995
SYSMEX SF-3000
K950508 · FPK
Sysmex Corp.
Hematology · 270d
Cleared Nov 03, 1995
ACL FUTURA COAGULATION SYSTEM
K951891 · JPA
Instrumentation Laboratory CO
Hematology · 193d
Cleared Nov 03, 1995
MICROSPIN 24
K953519 · GKF
Vulcon Technologies
Hematology · 99d
Cleared Nov 03, 1995
OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL
K954188 · GKZ
Immunotech Corp.
Hematology · 58d
Cleared Oct 31, 1995
ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS
K953870 · GKN
Medtronic Vascular
Hematology · 75d
Cleared Oct 30, 1995
CRYO CHECK NORMAL HUMAN REFERENCE PLASMA
K952622 · GGN
Precision Biologicals, Inc.
Hematology · 144d
Cleared Oct 30, 1995
CRYO CHECK ABNORMAL REFERENCE CHECK I & II
K952624 · GGC
Precision Biologicals, Inc.
Hematology · 144d
Cleared Oct 27, 1995
PROTIME MICROCOAGULATION SYSTEM
K951072 · GKP
International Technidyne Corp.
Hematology · 233d
Cleared Oct 25, 1995
AGEN DIMERTEST GOLD EIA
K945642 · GHH
Agen Biomedical , Ltd.
Hematology · 343d
Cleared Oct 24, 1995
B-FACT, BORDERLINE FACTOR ASSAY CONTROL
K945854 · GGN
George King Bio-Medical, Inc.
Hematology · 344d
Cleared Oct 24, 1995
A-FACT, ABNORMAL FACTOR ASSAY CONTROL
K945855 · GGN
George King Bio-Medical, Inc.
Hematology · 344d
Cleared Oct 20, 1995
IL682, CO-OXIMETER
K945677 · GKR
Instrumentation Laboratory CO
Hematology · 336d
Cleared Oct 20, 1995
PROTEIN C DEFICIENT PLASMA
K945857 · GJT
George King Bio-Medical, Inc.
Hematology · 340d
Cleared Oct 20, 1995
OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES
K946335 · GKZ
Immunotech, Inc.
Hematology · 295d
Cleared Oct 20, 1995
THROMBOPLASTIN-LI REAGENT
K951820 · GJS
Helena Laboratories
Hematology · 183d
Cleared Oct 19, 1995
VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT
K940003 · GKZ
Buckman Co., Inc.
Hematology · 654d
Cleared Oct 19, 1995
CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER
K951496 · GKZ
Abbott Laboratories
Hematology · 248d