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
1225–1248 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Feb 09, 1996
ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P
K952337 · LCP
Roche Diagnostic Systems, Inc.
Hematology · 266d
Cleared Feb 09, 1996
CHROM Z-F:VIII, CAT. NO. 5241
K952668 · GGP
Helena Laboratories
Hematology · 242d
Cleared Feb 08, 1996
COULTER LINEARITY CONTROL
K955334 · JPK
Coulter Corp.
Hematology · 80d
Cleared Feb 05, 1996
PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)
K954898 · GGT
Genzyme Corp.
Hematology · 138d
Cleared Feb 05, 1996
QBC ACCUREAD SYSTEM
K955504 · GKZ
Becton Dickinson Diagnostic...
Hematology · 66d
Cleared Jan 31, 1996
AT-III CONTROL PLASMA KIT
K955040 · GGC
American Bioproducts Co.
Hematology · 89d
Cleared Jan 30, 1996
CHROM Z-PROTEIN C, CAT. NO. 5243
K952666 · GGP
Helena Laboratories
Hematology · 232d
Cleared Jan 30, 1996
THROMBELASTOGRAPH COAGULATION ANALYZER 3000S
K954437 · GKP
Haemoscope Corp.
Hematology · 130d
Cleared Jan 30, 1996
4C PLUS COULTER CELL CONTROL
K955016 · JPK
Coulter Corp.
Hematology · 89d
Cleared Jan 26, 1996
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED,...
K945212 · GKZ
Dako Corp.
Hematology · 458d
Cleared Jan 24, 1996
CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT
K954997 · JOZ
Centocor, Inc.
Hematology · 84d
Cleared Jan 23, 1996
COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY
K952515 · JBQ
Chromogenix AB
Hematology · 237d
Cleared Jan 03, 1996
CRYO CHECK LOW FIBRINOGEN CONTROL
K951823 · GGN
Precision Biologicals, Inc.
Hematology · 258d
Cleared Dec 21, 1995
CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION
K950916 · GKZ
Caltag Laboratories, Inc.
Hematology · 295d
Cleared Dec 21, 1995
CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
K950917 · GKZ
Caltag Laboratories, Inc.
Hematology · 295d
Cleared Dec 21, 1995
CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION
K950918 · GKZ
Caltag Laboratories, Inc.
Hematology · 295d
Cleared Dec 21, 1995
CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION
K951073 · GKZ
Caltag Laboratories, Inc.
Hematology · 288d
Cleared Dec 20, 1995
CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
K950919 · GKZ
Caltag Laboratories, Inc.
Hematology · 294d
Cleared Dec 19, 1995
IMAGN(TM) 2000 SYSTEM
K945756 · GKZ
Buckman Co., Inc.
Hematology · 391d
Cleared Dec 07, 1995
CHROM Z-PLASMINOGEN, CAT. NO. 5244
K952669 · GGP
Helena Laboratories
Hematology · 178d
Cleared Nov 30, 1995
SYNTHASIL APTT REAGENT
K953981 · GFO
Ortho Diagnostic Systems, Inc.
Hematology · 99d
Cleared Nov 21, 1995
COAGUCHEK SYSTEM
K952625 · JPA
Boehringer Mannheim Corp.
Hematology · 166d
Cleared Nov 20, 1995
COACUTE HEPARIN
K952514 · KFF
Chromogenix AB
Hematology · 173d
Cleared Nov 20, 1995
FACS LOADER SYSTEM
K953302 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 129d