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
1009–1032 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL III
K981255 · GGN
Sigma Diagnostics, Inc.
Hematology · 23d
Cleared Apr 27, 1998
THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS
K981178 · GGN
Cardiovascular Diagnostics, Inc.
Hematology · 26d
Cleared Apr 24, 1998
ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS
K980614 · GKZ
Abbott Laboratories
Hematology · 81d
Cleared Apr 21, 1998
IL TEST PROTEIN C
K980875 · GGP
Instrumentation Laboratory CO
Hematology · 46d
Cleared Apr 16, 1998
MDA D-DIMER
K974776 · DAP
Organon Teknika Corp.
Hematology · 115d
Cleared Apr 16, 1998
AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2
K980982 · GGN
Avocet Medical, Inc.
Hematology · 30d
Cleared Apr 16, 1998
COAMATIC FACTOR VIII
K981038 · GGP
Instrumentation Laboratory CO
Hematology · 28d
Cleared Apr 08, 1998
FETAL D TECTION KIT
K980314 · LIM
Biopool Intl., Inc.
Hematology · 71d
Cleared Apr 02, 1998
IL TEST ANTITHROMBIN
K980499 · JBQ
Instrumentation Laboratory CO
Hematology · 52d
Cleared Mar 19, 1998
IL TEST HEPARIN
K980242 · KFF
Instrumentation Laboratory CO
Hematology · 55d
Cleared Mar 11, 1998
MULTITEST CD3/CD8/CD45/CD4
K974360 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 112d
Cleared Mar 11, 1998
CO-STAT(TM) END TIDAL BREATH ANALYZER
K974805 · GHS
Natus Medical, Inc.
Hematology · 78d
Cleared Mar 10, 1998
VIDAS D-DIMER (DD) ASSAY
K973819 · DAP
Biomerieux Vitek, Inc.
Hematology · 154d
Cleared Feb 24, 1998
MDA SIMPLASTIN HTF
K974566 · GJS
Organon Teknika Corp.
Hematology · 81d
Cleared Feb 17, 1998
FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET
K973483 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 155d
Cleared Jan 09, 1998
COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING
K974569 · JPA
Boehringer Mannheim Corp.
Hematology · 32d
Cleared Dec 24, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
K974110 · JBQ
Beckman Instruments, Inc.
Hematology · 54d
Cleared Dec 18, 1997
IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE...
K974396 · CHL
Diametrics Medical, Inc.
Hematology · 27d
Cleared Dec 01, 1997
TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES
K971205 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 244d
Cleared Nov 25, 1997
TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP
K971110 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 244d
Cleared Nov 24, 1997
SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT
K973696 · LCP
Beckman Instruments, Inc.
Hematology · 59d
Cleared Nov 21, 1997
TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP
K965053 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 338d
Cleared Nov 21, 1997
TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP
K970326 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 297d
Cleared Nov 20, 1997
HEMOCHRON CITRATE APTT
K972831 · GFO
International Technidyne Corp.
Hematology · 113d