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
6313–6336 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 14, 1992
ENZYMUN-TEST TSH
K915195 · JLW
Boehringer Mannheim Corp.
Chemistry · 87d
Cleared Feb 14, 1992
AFFINITY B12
K920078 · CDD
Bd Becton Dickinson Vacutainer...
Chemistry · 37d
Cleared Feb 14, 1992
MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT
K920253 · JHI
Medix Biotech, Inc.
Chemistry · 24d
Cleared Feb 06, 1992
MILENIA TOTAL T3
K914467 · CDP
Diagnostic Products Corp.
Chemistry · 122d
Cleared Feb 06, 1992
N/T PROTEIN CONTROL UY
K914890 · JJY
Behring Diagnostics, Inc.
Chemistry · 98d
Cleared Feb 06, 1992
DOCUMENT CK ISOENZYMES CONTROL
K915792 · CDP
Casco Standards
Chemistry · 44d
Cleared Jan 30, 1992
CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL
K912027 · CIC
Enzyme Technology, Inc.
Chemistry · 267d
Cleared Jan 30, 1992
CHOLESTEROL REGEANT SET
K914160 · CHH
Tech Intl. Co.
Chemistry · 135d
Cleared Jan 30, 1992
BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST
K914885 · CEK
Beckman Instruments, Inc.
Chemistry · 92d
Cleared Jan 30, 1992
AMYLASE (COLORIMETRIC) REAGENT SET
K915710 · JFJ
Tech Intl. Co.
Chemistry · 62d
Cleared Jan 30, 1992
CALIBRATOR
K915797 · JIX
Alko Diagnostic Corp.
Chemistry · 37d
Cleared Jan 30, 1992
MILENIA DATA REDUCTION
K915806 · JJX
Diagnostic Products Corp.
Chemistry · 37d
Cleared Jan 28, 1992
ABL505 BLOOD GAS & ELECTROLYTE SYSTEM
K914166 · CHL
Radiometer America, Inc.
Chemistry · 133d
Cleared Jan 28, 1992
BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT
K915084 · CDT
Beckman Instruments, Inc.
Chemistry · 77d
Cleared Jan 28, 1992
DIMENSION AR CLINICAL CHEMISTRY SYSTEM
K915106 · JJE
Dupont Medical Products
Chemistry · 76d
Cleared Jan 28, 1992
CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT
K915235 · CDX
Incstar Corp.
Chemistry · 67d
Cleared Jan 27, 1992
GLUCOSE REAGENT SET
K914159 · CGA
Tech Intl. Co.
Chemistry · 132d
Cleared Jan 27, 1992
MP MINI PHOTOMETER
K914809 · JJX
Artel, Inc.
Chemistry · 94d
Cleared Jan 27, 1992
IL TEST(TM) BENZODIAZEPINE
K914815 · JXM
Instrumentation Laboratory CO
Chemistry · 94d
Cleared Jan 27, 1992
NOVA 5 NA/K/C1 ALALYZER
K915177 · CEM
Nova Biomedical Corp.
Chemistry · 73d
Cleared Jan 27, 1992
NOVA 11 NA/K/LI ANALYZER
K915178 · CEM
Nova Biomedical Corp.
Chemistry · 73d
Cleared Jan 27, 1992
SYNERMED AST/GOT REAGENT KIT
K915555 · CIT
Synermed, Inc.
Chemistry · 47d
Cleared Jan 27, 1992
GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT
K915570 · CDZ
Incstar Corp.
Chemistry · 46d
Cleared Jan 27, 1992
KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION
K915701 · JHI
Eastman Kodak Company
Chemistry · 49d