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
649–672 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jan 31, 2003
MODIFICATION TO PENTRA 60 AND PENTRA 60C+
K030144 · GKZ
Abx Diagnostics
Hematology · 16d
Cleared Jan 16, 2003
STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
K022976 · DAP
Dade Behring, Inc.
Hematology · 132d
Cleared Jan 16, 2003
MODIFICATION TO STANDARD HUMAN PLASMA
K023141 · JPA
Dade Behring, Inc.
Hematology · 118d
Cleared Jan 14, 2003
HEMOSIL FACTOR V DEFICIENT PLASMA
K023839 · GJT
Instrumentation Laboratory CO
Hematology · 57d
Cleared Jan 14, 2003
CDS 3-PD HEMATOLOGY CONTROLS
K024173 · JPK
Clinical Diagnostic Solutions, Inc.
Hematology · 27d
Cleared Jan 03, 2003
PENTRA 80
K024002 · GKZ
Abx Diagnostics
Hematology · 30d
Cleared Dec 30, 2002
SICKLE-CHEX SOLUBILITY KIT
K023656 · GHM
Streck Laboratories, Inc.
Hematology · 61d
Cleared Dec 13, 2002
A1CNOW FOR HOME USE
K022661 · LCP
Metrika, Inc.
Hematology · 126d
Cleared Dec 09, 2002
FISHER DIAGNOSTICS THROMBOSCREEN 1000
K023362 · GKP
Fisher Diagnostics
Hematology · 63d
Cleared Nov 27, 2002
STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C
K022977 · DAP
Dade Behring, Inc.
Hematology · 82d
Cleared Nov 01, 2002
VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT
K022021 · GFO
Vital Scientific N.V.
Hematology · 134d
Cleared Nov 01, 2002
CONTROL PLASMA N
K023309 · GIZ
Dade Behring, Inc.
Hematology · 29d
Cleared Nov 01, 2002
CONTROL PLASMA P
K023312 · GGC
Dade Behring, Inc.
Hematology · 29d
Cleared Oct 25, 2002
PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
K021190 · GJS
Roche Diagnostics Corp.
Hematology · 193d
Cleared Oct 25, 2002
FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON
K021976 · KQG
Vital Scientific N.V.
Hematology · 130d
Cleared Oct 24, 2002
PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND...
K020831 · GJS
Roche Diagnostics Corp.
Hematology · 224d
Cleared Oct 24, 2002
INRATIO SELF-TEST
K021923 · GJS
Hemosense, Inc.
Hematology · 135d
Cleared Oct 15, 2002
ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD
K022668 · GKZ
Bayer Diagnostics Corp.
Hematology · 64d
Cleared Oct 03, 2002
VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
K020810 · DAP
bioMerieux, Inc.
Hematology · 204d
Cleared Sep 30, 2002
CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518
K022512 · GKH
Immunicon Corp.
Hematology · 62d
Cleared Sep 30, 2002
HARMONY INR MONITORING SYSTEM
K022922 · GJS
Lifescan, Inc.
Hematology · 26d
Cleared Sep 24, 2002
LIFEGUARD
K022755 · KHE
Medtek, LLC
Hematology · 35d
Cleared Sep 24, 2002
ADVIA TESTPOINT CSF CONTROL
K022968 · JPK
Bayer Diagnostics Corp.
Hematology · 18d
Cleared Sep 20, 2002
SQA V, SPERM QUALITY ANALYZER
K021746 · POV
Medical Electronic Systems, LLC
Hematology · 115d