FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
6697–6720 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 26, 1990
CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL
K905296 · LBS
Cholestech Corp.
Chemistry · 29d
Cleared Dec 26, 1990
CHEM-CHEX LIPID
K905389 · JJY
Streck Laboratories, Inc.
Chemistry · 26d
Cleared Dec 26, 1990
COULTER DIRECT BILLRUBIN REAGENT
K905622 · CIG
Coulter Electronics, Inc.
Chemistry · 12d
Cleared Dec 20, 1990
KETOREX SANWA STANDARDS
K903365 · JIN
Ihara Medics U.S., Inc.
Chemistry · 147d
Cleared Dec 20, 1990
MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT
K903993 · DKZ
Immunotech Corp.
Chemistry · 113d
Cleared Dec 20, 1990
RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV
K905084 · CGS
Reagents Applications, Inc.
Chemistry · 36d
Cleared Dec 20, 1990
RAICHEM GGT REAGENT
K905085 · JQB
Reagents Applications, Inc.
Chemistry · 36d
Cleared Dec 18, 1990
LYTENING TM 6/R
K904726 · JFP
Amdev, Inc.
Chemistry · 62d
Cleared Dec 18, 1990
CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL
K904781 · JJY
Cholestrech Corp.
Chemistry · 57d
Cleared Dec 18, 1990
CHOLESTECH L.D.X. LEVEL 1 CONTROL
K904784 · JJY
Cholestech Corp.
Chemistry · 57d
Cleared Dec 18, 1990
ELEGANCE TSH ELISA
K905099 · JLW
Bioclone Australia Pty , Ltd.
Chemistry · 35d
Cleared Dec 13, 1990
ABL510 BLOOD GAS SYSTEM
K904513 · CHL
Radiometer America, Inc.
Chemistry · 72d
Cleared Dec 13, 1990
COULTER CK-MB ISOENZYME REAGENT
K904866 · JHT
Coulter Electronics, Inc.
Chemistry · 45d
Cleared Dec 11, 1990
AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116
K904004 · CGS
Amresco, Inc.
Chemistry · 104d
Cleared Dec 11, 1990
DOA LIQUID MULTI-ANALYTE DRUGS OF ABUSE CONTROLS
K904905 · DIF
Medical Analysis Systems, Inc.
Chemistry · 42d
Cleared Dec 11, 1990
TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL
K905226 · JGY
Enzyme Technology, Inc.
Chemistry · 21d
Cleared Dec 11, 1990
HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173
K905284 · LBR
Amresco, Inc.
Chemistry · 18d
Cleared Dec 07, 1990
LDL-DIRECT CONTROLS
K902740 · JJY
Isolab, Inc.
Chemistry · 168d
Cleared Dec 07, 1990
HDL CHOLESTEROL CONTROL
K904872 · JJY
Analytical Control Systems, Inc.
Chemistry · 38d
Cleared Dec 06, 1990
CLINICAL CHEMISTRY CONTROL
K904075 · JJY
Phoenix Diagnostics, Inc.
Chemistry · 93d
Cleared Dec 06, 1990
ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST
K904782 · LCX
Carter Products
Chemistry · 45d
Cleared Dec 06, 1990
ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL
K904829 · JJY
Analytical Control Systems, Inc.
Chemistry · 42d
Cleared Dec 06, 1990
QCLYTE PROTEIN BASED ISE CONTROL
K904968 · JJY
Baxter Healthcare Corp
Chemistry · 31d
Cleared Dec 06, 1990
ELEGANCE GH ELISA
K905098 · CFL
Bioclone Australia Pty , Ltd.
Chemistry · 23d