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
1513–1536 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Mar 23, 1993
COAGULATION CONTROL CONTAINING HEMOGLOBIN
K925340 · JPA
Analytical Control Systems, Inc.
Hematology · 154d
Cleared Mar 23, 1993
MICROHEMATOCRIT ROTOR
K930415 · GKG
Fisher Scientific Co., LLC
Hematology · 56d
Cleared Mar 12, 1993
ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT
K925604 · GJS
Ortho Diagnostic Systems, Inc.
Hematology · 127d
Cleared Mar 11, 1993
VARIANT BETA-THALASSEMIA SHORT PROGRAM
K924122 · JPD
Bio-Rad
Hematology · 209d
Cleared Mar 09, 1993
FIBRINOGEN RID TEST KIT
K922416 · KQJ
The Binding Site, Ltd.
Hematology · 292d
Cleared Mar 01, 1993
QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL
K925256 · JJY
Quantimetrix Corp.
Hematology · 133d
Cleared Mar 01, 1993
MULTIFIBREN
K925988 · KQJ
Behring Diagnostics, Inc.
Hematology · 96d
Cleared Feb 25, 1993
CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM
K922887 · GGN
Precision Biologicals, Inc.
Hematology · 254d
Cleared Feb 12, 1993
NYCOPLASTIN
K920767 · GJS
Nycomed Pharma AS
Hematology · 359d
Cleared Feb 12, 1993
OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376
K926222 · JPA
Helena Laboratories
Hematology · 64d
Cleared Feb 05, 1993
CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1
K922744 · GKZ
Coulter Immunology
Hematology · 242d
Cleared Feb 05, 1993
CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1
K922745 · GKZ
Coulter Immunology
Hematology · 242d
Cleared Feb 05, 1993
CELLEXIS HEMATOLOGY ANALYZER
K923773 · GKZ
Technalysis, Inc.
Hematology · 196d
Cleared Feb 05, 1993
BIOVATION K-MANAGER
K925528 · GKZ
Biovation, Inc.
Hematology · 95d
Cleared Feb 05, 1993
SPUNCRIT
K925863 · GKG
bioMerieux, Inc.
Hematology · 78d
Cleared Feb 03, 1993
BIOMERIEUX HEMOLAB THROMBOMAT
K925492 · GJS
Biomerieux Vitek, Inc.
Hematology · 93d
Cleared Jan 28, 1993
POWER SUPPLY
K924021 · JJN
The Binding Site, Ltd.
Hematology · 170d
Cleared Jan 27, 1993
HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT
K924637 · GFO
International Technidyne Corp.
Hematology · 148d
Cleared Jan 21, 1993
ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM
K923761 · JPA
International Technidyne Corp.
Hematology · 177d
Cleared Jan 21, 1993
COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA
K925344 · GKZ
Coulter Corp.
Hematology · 91d
Cleared Jan 14, 1993
HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT
K924638 · GFO
International Technidyne Corp.
Hematology · 135d
Cleared Jan 14, 1993
VARIANT SICKLE CELL SHORT PROGRAM
K924813 · GKA
Bio-Rad
Hematology · 111d
Cleared Jan 14, 1993
IL TEST(TM) PRO-CHROM
K924884 · GGP
Instrumentation Laboratory CO
Hematology · 108d
Cleared Jan 12, 1993
BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED
K925204 · LCP
Beckman Instruments, Inc.
Hematology · 98d