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
1057–1080 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Aug 29, 1997
ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
K971998 · GKL
Bayer Corp.
Hematology · 91d
Cleared Aug 26, 1997
TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS
K970836 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 183d
Cleared Aug 26, 1997
SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER
K971736 · GKZ
Sysmex Corp.
Hematology · 106d
Cleared Aug 19, 1997
CRYO CHECK APC RESISTANT PLASMA
K971222 · GGN
Precision Biologicals, Inc.
Hematology · 139d
Cleared Aug 19, 1997
ASSERACHROM TPA TEST KIT
K971519 · GGP
American Bioproducts Co.
Hematology · 116d
Cleared Aug 18, 1997
TRACCELL 2000 SLIDE MAPPING SYSTEM
K964689 · JOY
Accumed Intl., Inc.
Hematology · 269d
Cleared Aug 13, 1997
REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT
K972005 · GGP
Reaads Medical Products, Inc.
Hematology · 75d
Cleared Aug 13, 1997
REAADS PROTEIN S ANTIGEN TEST KIT
K972482 · GGP
Reaads Medical Products, Inc.
Hematology · 42d
Cleared Aug 13, 1997
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN...
K972627 · GJT
Pacific Hemostasis
Hematology · 30d
Cleared Aug 12, 1997
ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)
K971152 · GKZ
Abbott Laboratories
Hematology · 137d
Cleared Aug 12, 1997
SPECTROLYSE HEPARIN (ANTI-IIA)
K972209 · KFF
Medical Diagnostic Technologies, Inc.
Hematology · 62d
Cleared Aug 06, 1997
VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
K972609 · LCQ
Bio-Rad
Hematology · 26d
Cleared Jul 25, 1997
VON WILLEBRAND REAGENT
K972116 · GGP
Behring Diagnostics, Inc.
Hematology · 50d
Cleared Jul 25, 1997
SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III
K972144 · JBQ
Sigma Diagnostics, Inc.
Hematology · 49d
Cleared Jul 24, 1997
ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION
K972170 · JPK
R&D Systems, Inc.
Hematology · 45d
Cleared Jul 24, 1997
ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION
K972172 · JPK
R&D Systems, Inc.
Hematology · 45d
Cleared Jul 22, 1997
CRYO CHECK FACTOR V DEFICIENT PLASMA
K971223 · GJT
Precision Biologicals, Inc.
Hematology · 111d
Cleared Jul 18, 1997
CRYO CHECK FACTOR IX DEFICIENT PLASMA
K971226 · GJT
Precision Biologicals, Inc.
Hematology · 107d
Cleared Jul 18, 1997
CRYO CHECK FACTOR X DEFICIENT PLASMA
K971227 · GJT
Precision Biologicals, Inc.
Hematology · 107d
Cleared Jul 17, 1997
CRYO CHECK FACTOR VII DEFICIENT PLASMA
K971224 · GJT
Precision Biologicals, Inc.
Hematology · 106d
Cleared Jul 17, 1997
CRYO CHECK FACTOR VIII DEFICIENT PLASMA
K971225 · GJT
Precision Biologicals, Inc.
Hematology · 106d
Cleared Jul 14, 1997
ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE
K951459 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 837d
Cleared Jul 14, 1997
FACTOR DEFICIENT PLASMAS - FACTOR XI (11)
K972286 · GJT
Universal Reagents, Inc.
Hematology · 25d
Cleared Jul 14, 1997
FACTOR DEFICIENT PLASMAS - FACTOR IX (9)
K972288 · GGP
Universal Reagents, Inc.
Hematology · 25d