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
697–720 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared May 23, 2002
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
K020914 · JBP
Helena Laboratories
Hematology · 63d
Cleared May 16, 2002
MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)
K013596 · JOZ
Accumetrics, Inc.
Hematology · 197d
Cleared May 16, 2002
HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
K021024 · GGN
Instrumentation Laboratory CO
Hematology · 48d
Cleared May 15, 2002
VITAL SCIENTIFIC PT WITH CALCIUM
K020840 · GJS
Vital Scientific N.V.
Hematology · 61d
Cleared May 14, 2002
I-STAT PROTHROMBIN TIME TEST
K020355 · GJS
I-Stat Corporation
Hematology · 99d
Cleared May 14, 2002
G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE
K020489 · JPD
Tosoh Medics, Inc.
Hematology · 90d
Cleared May 14, 2002
AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL
K020618 · GLK
Aalto Scientific, Ltd.
Hematology · 78d
Cleared May 14, 2002
HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED)
K021022 · GGN
Instrumentation Laboratory CO
Hematology · 46d
Cleared May 14, 2002
HEMOSIL NORMAL CONTROL (ASSAYED)
K021023 · GGN
Instrumentation Laboratory CO
Hematology · 46d
Cleared May 06, 2002
INRATIO
K020679 · GJS
Hemosense, Inc.
Hematology · 63d
Cleared Apr 24, 2002
POLYMEDCO HBA1C TEST
K020532 · LCP
Polymedco, Inc.
Hematology · 64d
Cleared Apr 16, 2002
ACTICHROME HEPARIN (ANTI-FIIA)
K013637 · KFF
American Diagnostica, Inc.
Hematology · 162d
Cleared Apr 15, 2002
LYPHOCHEK HEMOSTASIS, MODELS 798, 799
K020878 · GGC
Bio-Rad
Hematology · 28d
Cleared Apr 12, 2002
HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE...
K020496 · GKZ
Sysmex Corporation of America
Hematology · 57d
Cleared Apr 04, 2002
CAL-CHEX CD PLUS
K020469 · KRX
Streck Laboratories, Inc.
Hematology · 51d
Cleared Apr 02, 2002
IMMUNE CELL FUNCTION ASSAY
K013169 · NID
Cylex, Inc.
Hematology · 193d
Cleared Mar 28, 2002
HEMOCHRON JR. SIGNATURE +
K020798 · JPA
International Technidyne Corp.
Hematology · 16d
Cleared Mar 15, 2002
AUTODIMER ASSAY MODEL # 1431
K012755 · DAP
Xtrana, Inc.
Hematology · 211d
Cleared Mar 13, 2002
AUTOMARQER
K012805 · POV
Hamilton Thorne Research
Hematology · 204d
Cleared Mar 13, 2002
IMUBIND TPA ELISA, MODEL 860
K013492 · GGP
American Diagnostica, Inc.
Hematology · 142d
Cleared Mar 08, 2002
ACTICHROME HEPARIN (ANTI-FXA), MODEL 832
K013318 · KFF
American Diagnostica, Inc.
Hematology · 154d
Cleared Mar 07, 2002
IMUBIND PLASMA PAI-1 ELISA,MODEL 822
K013168 · GGP
American Diagnostica, Inc.
Hematology · 167d
Cleared Mar 05, 2002
ASTOFLO
K020060 · BSB
Nats Corp.
Hematology · 56d
Cleared Feb 28, 2002
ABX MICROS 60 HEMATOLOGY ANALYZER
K014203 · GKX
Abx Diagnostics
Hematology · 69d