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
1825–1848 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Mar 06, 1990
FACTOR II DEFICIENT PLASMA
K900906 · GJT
Sigma Chemical Co.
Hematology · 7d
Cleared Mar 02, 1990
COULTER CLONE T4 MONOCLONAL ANTIBODY
K893852 · GKZ
Coulter Immunology
Hematology · 281d
Cleared Mar 02, 1990
COULTER CLONE T8 MONOCLONAL ANTIBODY
K893853 · GKZ
Coulter Immunology
Hematology · 281d
Cleared Feb 12, 1990
COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY
K894179 · GKZ
Coulter Immunology
Hematology · 241d
Cleared Feb 05, 1990
PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357
K897136 · GGP
Helena Laboratories
Hematology · 40d
Cleared Feb 05, 1990
TT AND HNTT BY HEMOCHRON
K900126 · GJA
International Technidyne Corp.
Hematology · 27d
Cleared Jan 29, 1990
REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210)
K900017 · JPK
Helena Laboratories
Hematology · 27d
Cleared Jan 25, 1990
RESUBMITTED FECATWIN SENSITIVE - FECA-EIA
K896474 · KHE
Labsystems, Inc.
Hematology · 73d
Cleared Jan 25, 1990
RAICHEM TM HEMOGLOBIN CALIBRATOR
K896921 · KRZ
Reagents Applications, Inc.
Hematology · 45d
Cleared Jan 25, 1990
RAICHEM TM HEMOGLOBIN REAGENT
K896922 · GKK
Reagents Applications, Inc.
Hematology · 45d
Cleared Jan 25, 1990
ROCKET REFERENCE PLASMA, CAT NO. 5188
K900019 · GGN
Helena Laboratories
Hematology · 23d
Cleared Jan 25, 1990
APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT
K900049 · GFO
Medical Diagnostic Technologies, Inc.
Hematology · 22d
Cleared Jan 25, 1990
FACTOR II DEFICIENT PLASMA
K900133 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 15d
Cleared Jan 18, 1990
HEMOGLOBIN A2 MICRO COLUMN TEST
K896168 · JPD
Bio-Rad
Hematology · 85d
Cleared Jan 02, 1990
CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE
K897060 · KSA
R&D Systems, Inc.
Hematology · 15d
Cleared Dec 29, 1989
SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN
K890349 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 339d
Cleared Dec 29, 1989
SQA
K894949 · POV
United Medical Systems, Inc.
Hematology · 148d
Cleared Dec 29, 1989
CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI
K895917 · GKZ
Coulter Immunology
Hematology · 80d
Cleared Dec 11, 1989
CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER
K896334 · LCP
Creative Laboratory Products, Inc.
Hematology · 38d
Cleared Dec 11, 1989
CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR
K896335 · LCP
Creative Laboratory Products, Inc.
Hematology · 38d
Cleared Dec 11, 1989
THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER.
K896625 · GJS
Medical Diagnostic Technologies, Inc.
Hematology · 20d
Cleared Dec 07, 1989
GLYCOTEST II GLYHB ASSAY KIT
K895661 · LCP
Pierce Chemical Co.
Hematology · 78d
Cleared Dec 01, 1989
ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)
K896545 · GFO
Sigma Chemical Co.
Hematology · 14d
Cleared Nov 29, 1989
SICKLE CELL SOLUBILITY TEST KIT
K895745 · JBB
Simmler, Inc.
Hematology · 64d