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
6649–6672 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 13, 1991
STRATUS ESTRADIOL FLUOREMETRIC ENZYME
K910249 · CHP
Baxter Healthcare Corp
Chemistry · 22d
Cleared Feb 11, 1991
HEMASTIX REAGENT STRIPS
K905396 · JIO
Heraeus Kulzer, Inc.
Chemistry · 73d
Cleared Feb 06, 1991
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH
K905861 · CFE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 37d
Cleared Feb 04, 1991
OLYMPUS URINE PH
K905146 · JQY
Diagnostic Systems
Chemistry · 81d
Cleared Feb 04, 1991
BIOTROL BILIRUBIN C & T CONTROL
K905280 · JJX
Biotrol, USA, Inc.
Chemistry · 73d
Cleared Feb 04, 1991
LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY
K905814 · CGJ
London Diagnostics, Inc.
Chemistry · 38d
Cleared Feb 04, 1991
ELECTRAPETTE (R)
K910140 · JQW
Matrix Technologies Corp.
Chemistry · 21d
Cleared Feb 04, 1991
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE)
K910143 · JIY
Eastman Kodak Company
Chemistry · 21d
Cleared Feb 04, 1991
CIBA CORNING ACS LH IMMUNOASSAY
K910198 · CEP
Ciba Corning Diagnostics Corp.
Chemistry · 19d
Cleared Feb 01, 1991
IMMULITE (TM) TOTAL T3
K905214 · CDP
Cirrus Diagnostics, Inc.
Chemistry · 73d
Cleared Jan 31, 1991
UBI MAGIWEL CORTISOL QUANTITATIVE
K905473 · CGR
United Biotech, Inc.
Chemistry · 56d
Cleared Jan 31, 1991
KINETIC AMYLASE DETERMINATION
K905651 · JFJ
Biochemical Trade, Inc.
Chemistry · 44d
Cleared Jan 31, 1991
SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420
K905661 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 44d
Cleared Jan 31, 1991
IMMULITE HS-TSH
K905769 · JLW
Cirrus Diagnostics, Inc.
Chemistry · 35d
Cleared Jan 30, 1991
GAMMA-GLUTAMYL TRANSFERASE DETERMINATION
K905649 · JQB
Biochemical Trade, Inc.
Chemistry · 43d
Cleared Jan 30, 1991
DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS
K905829 · CEL
Kamiya Biomedical Co.
Chemistry · 30d
Cleared Jan 25, 1991
QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM
K904603 · CEK
Quantitative Medicine, Inc.
Chemistry · 107d
Cleared Jan 25, 1991
COLUMNS LIQUID CHROMATOGRAPHY DPM
K905538 · KZR
Millpore Corp.
Chemistry · 45d
Cleared Jan 25, 1991
SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401
K905660 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Jan 25, 1991
AIA-PACK HGH
K905757 · CFL
Tosoh Medics, Inc.
Chemistry · 29d
Cleared Jan 25, 1991
COULTER DART ALT (GPT) REAGENT
K905767 · CKA
Coulter Electronics, Inc.
Chemistry · 29d
Cleared Jan 23, 1991
SEROZYME CORTISOL TEST KIT
K903975 · CGR
Serono-Baker Diagnostics, Inc.
Chemistry · 148d
Cleared Jan 23, 1991
CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II
K904989 · JJY
Creative Laboratory Products, Inc.
Chemistry · 77d
Cleared Jan 23, 1991
IMX FREE TRIIODOTHYRONINE
K905261 · CDP
Abbott Laboratories
Chemistry · 63d