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
6793–6816 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 27, 1990
GEN-PROBE LUMINOMETER-LEADER 50
K903934 · JJQ
Gen-Probe, Inc.
Chemistry · 31d
Cleared Sep 27, 1990
SYNERMED ALKALINE PHOSPHATASE REAGENT KIT
K904030 · CJE
Synermed, Inc.
Chemistry · 27d
Cleared Sep 27, 1990
CEDIA TOTAL T3 ASSAY
K904098 · CDP
Microgenics Corp.
Chemistry · 21d
Cleared Sep 27, 1990
REFLOTRON CREATINE KINASE TEST TABS
K904102 · CGS
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Sep 27, 1990
IRON 5 X CONC REAGENT
K904116 · JMO
Trace Scientific , Ltd.
Chemistry · 21d
Cleared Sep 27, 1990
CIBA CORNING MODEL 238 PH/ BLOOD GAS ANALYZER
K904188 · CHL
Ciba Corning Diagnostics Corp.
Chemistry · 15d
Cleared Sep 25, 1990
LIQUID STABLE CHOLESTEROL REAGENT KIT
K902678 · CHH
Trace Scientific , Ltd.
Chemistry · 98d
Cleared Sep 25, 1990
LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY
K903130 · CEW
London Diagnostics, Inc.
Chemistry · 70d
Cleared Sep 25, 1990
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (ECO2)
K903144 · KHS
Eastman Kodak Company
Chemistry · 69d
Cleared Sep 25, 1990
LABMASTER BETA-2-MICROGLOBULIN ELISA TEST KIT TM
K903215 · JZG
Bioproducts For Science, Inc.
Chemistry · 64d
Cleared Sep 25, 1990
ABBOTT TESTPACK PLUS TM HCG-COMBO
K903219 · JHI
Abbott Laboratories
Chemistry · 64d
Cleared Sep 25, 1990
AST REAGENT
K903829 · CIT
Amresco, Inc.
Chemistry · 35d
Cleared Sep 21, 1990
VEN-O-VAC BLOOD COLLECTION VACUUM TUBES
K900856 · JKA
Artefactos DE Vidrio S.A. DE C.V.
Chemistry · 210d
Cleared Sep 21, 1990
MILENIA PAP IRMA CATALOG #: MKPA1, X
K902937 · JFH
Diagnostic Products Corp.
Chemistry · 80d
Cleared Sep 21, 1990
SYNERMED DIRECT BILIRUBIN REAGENT KIT
K903728 · CIG
Synermed, Inc.
Chemistry · 36d
Cleared Sep 17, 1990
TRI-TECH URINE SPECIMEN KIT
K900983 · FMH
Tri-Tech, Inc.
Chemistry · 199d
Cleared Sep 14, 1990
RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT
K903123 · JIQ
Reagents Applications, Inc.
Chemistry · 60d
Cleared Sep 13, 1990
SYNERMED GLUCOSE REAGENT KIT
K903063 · CGA
Synermed, Inc.
Chemistry · 66d
Cleared Sep 13, 1990
CALCIUM ARSENAZO III REAGENT
K903896 · CIC
Trace Scientific , Ltd.
Chemistry · 21d
Cleared Sep 13, 1990
BICARBONATE REAGENTS AMRESCO PRODUCT #4326020
K904007 · KHS
Amresco, Inc.
Chemistry · 15d
Cleared Sep 12, 1990
ALANINE AMINOTRANSFERASE TEST
K903198 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 55d
Cleared Sep 12, 1990
OLYMPUS INORGANIC PHOSPHORUS
K903696 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Sep 11, 1990
MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE
K903647 · LDM
Millipore Corp.
Chemistry · 33d
Cleared Sep 10, 1990
CIBA CORNING ACS DIGOXIN IMMUNOASSAY
K902861 · DON
Ciba Corning Diagnostics Corp.
Chemistry · 74d