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
1129–1152 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Dec 10, 1996
THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451
K961908 · JPA
Helena Laboratories
Hematology · 208d
Cleared Nov 29, 1996
QUANTITATIVE FIBRINOGEN ASSAY
K963902 · GIS
Ortho Diagnostic Systems, Inc.
Hematology · 63d
Cleared Nov 25, 1996
CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY
K963954 · GKZ
Caltag Laboratories, Inc.
Hematology · 54d
Cleared Nov 18, 1996
CHROMOLIZE PAI-1 KIT
K963106 · GGP
Medical Diagnostic Technologies, Inc.
Hematology · 98d
Cleared Nov 15, 1996
SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY
K962825 · GGP
Shield Diagnostics, Ltd.
Hematology · 119d
Cleared Nov 06, 1996
FLEXSURE OBT
K961062 · KHE
Smithkline Diagnostics, Inc.
Hematology · 233d
Cleared Nov 06, 1996
HEMOCUE HEMOTROL
K964052 · GGM
Direct Solutions
Hematology · 37d
Cleared Nov 04, 1996
VEGA HEMATOLOGY ANALYZER
K962633 · GKZ
Abx, Inc.
Hematology · 122d
Cleared Oct 30, 1996
COULTER GEN-S SYSTEM
K962988 · GKL
Coulter Corp.
Hematology · 90d
Cleared Oct 25, 1996
STA - LIATEST VWF TEST KIT
K962675 · GJT
American Bioproducts Co.
Hematology · 108d
Cleared Oct 22, 1996
CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592
K962426 · JOZ
Chrono-Log Corp.
Hematology · 120d
Cleared Oct 18, 1996
MICRO HAEMATOCRIT CENTRIFUGE
K960491 · CKG
Hawksley & Sons , Ltd.
Hematology · 260d
Cleared Oct 18, 1996
ABBOTT CELL-DYN 4000 SYSTEM
K961439 · GKZ
Abbott Diagnostics
Hematology · 186d
Cleared Oct 18, 1996
TPP
K962176 · MIF
Panbio, Inc.
Hematology · 135d
Cleared Oct 16, 1996
HEMOCUE HEMOLIN
K963908 · GGM
Direct Solutions
Hematology · 16d
Cleared Oct 10, 1996
FACTOR DEFICIENT PLASMA
K961929 · GGP
Universal Reagents, Inc.
Hematology · 146d
Cleared Oct 08, 1996
CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
K955715 · GKZ
Abbott Laboratories
Hematology · 313d
Cleared Sep 24, 1996
HEMOCUE B-HEMOGLOBIN SYSTEM
K961312 · GKR
Hemocue, Inc.
Hematology · 173d
Cleared Sep 13, 1996
STA-VWF CALIBRATOR KIT
K962671 · GJT
American Bioproducts Co.
Hematology · 66d
Cleared Sep 10, 1996
KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)
K960875 · JPA
Sigma Diagnostics, Inc.
Hematology · 190d
Cleared Sep 10, 1996
ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER
K962664 · GKP
Medical Laboratory Automation...
Hematology · 63d
Cleared Sep 04, 1996
ACL 6000 SYSTEM (ACL 6000)
K961991 · GKP
Instrumentation Laboratory CO
Hematology · 106d
Cleared Aug 30, 1996
RETICULOCYTE METHOD
K954607 · GKL
Bayer Corp.
Hematology · 331d
Cleared Aug 23, 1996
RETICULOCYTE METHOD, RBC INDICES
K954594 · GKZ
Bayer Corp.
Hematology · 325d