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
601–624 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Dec 08, 2003
KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501
K032827 · KSR
Tyco Healthcare
Hematology · 89d
Cleared Dec 08, 2003
POTENS +
K033137 · JPA
Wada, Inc.
Hematology · 69d
Cleared Nov 24, 2003
IMMUNICON CELLTRACKS ANALYZER
K030263 · GKZ
Immunicon Corp.
Hematology · 301d
Cleared Nov 24, 2003
HBA SPERM-HYALURONAN BINDING ASSAY
K032874 · POV
Biocoat, Inc.
Hematology · 70d
Cleared Nov 03, 2003
CRYOCHECK WEAK LUPUS POSITIVE CONTROL
K032804 · GGC
Precision Biologic
Hematology · 55d
Cleared Oct 24, 2003
QUANTEX D-DIMER
K032419 · DAP
Instrumentation Laboratory CO
Hematology · 80d
Cleared Oct 24, 2003
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
K032482 · GKR
Stanbio Laboratory
Hematology · 73d
Cleared Sep 26, 2003
COULTER LH 750 HEMATOLOGY ANALYZER
K032342 · GKZ
Beckman Coulter, Inc.
Hematology · 59d
Cleared Sep 24, 2003
HEMAPROMPT GASTRIC
K031356 · KHE
Aerscher Diagnostics
Hematology · 166d
Cleared Sep 24, 2003
EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
K031898 · GKR
Ekf Diagnostic GmbH
Hematology · 97d
Cleared Sep 17, 2003
LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
K032611 · GGN
Bio-Rad
Hematology · 23d
Cleared Sep 08, 2003
I-STAT KAOLIN ACT TEST
K023582 · JBP
I-Stat Corporation
Hematology · 319d
Cleared Sep 08, 2003
SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540....
K031377 · GKP
Dade Behring, Inc.
Hematology · 130d
Cleared Sep 08, 2003
IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED...
K032039 · GKZ
Sysmex America, Inc.
Hematology · 69d
Cleared Sep 08, 2003
ADVIA 60 HEMATOLOGY ANALYZER
K032524 · GKZ
Bayer Healthcare, LLC
Hematology · 24d
Cleared Sep 02, 2003
VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
K030328 · DAP
bioMerieux, Inc.
Hematology · 214d
Cleared Aug 25, 2003
HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
K032203 · GKR
Hemocue, Inc.
Hematology · 38d
Cleared Aug 20, 2003
DUET SYSTEM
K030192 · JOY
Bioview , Ltd.
Hematology · 211d
Cleared Aug 13, 2003
COULTER LH 500 HEMATOLOGY ANALYZER
K032000 · GKZ
Beckman Coulter, Inc.
Hematology · 64d
Cleared Aug 08, 2003
LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3
K032017 · GGN
Bio-Rad
Hematology · 39d
Cleared Jul 31, 2003
HEMOSIL FACTOR IX DEFICIENT PLASMA
K031829 · GJT
Instrumentation Laboratory CO
Hematology · 48d
Cleared Jul 24, 2003
COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
K032013 · GKZ
Beckman Coulter, Inc.
Hematology · 24d
Cleared Jul 03, 2003
GENERAL SEMEN ANALYSIS (GSA) KIT
K024337 · POV
Bioshaf , Ltd.
Hematology · 188d
Cleared Jul 02, 2003
SECQUIRE CELL SEPARATOR
K024080 · JQC
Perfusion Partners & Assoc., Inc.
Hematology · 204d