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
7105–7128 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 16, 1990
COBAS READY CHOLESTEROL REAGENT
K896239 · CHH
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY CK REAGENT
K896240 · JHY
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY LDH REAGENT
K896241 · CFJ
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT
K896440 · JIR
Kenlor Industries, Inc.
Chemistry · 99d
Cleared Feb 16, 1990
MODIFIED PARAMAX URIC ACID REAGENT
K896521 · KNK
Baxter Healthcare Corp
Chemistry · 93d
Cleared Feb 16, 1990
MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT
K896587 · JHI
Medix Biotech, Inc.
Chemistry · 87d
Cleared Feb 16, 1990
RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT
K896845 · CDL
Reagents Applications, Inc.
Chemistry · 72d
Cleared Feb 16, 1990
CENTRIPREP 100
K900280 · JJP
Amicon, Inc.
Chemistry · 29d
Cleared Feb 13, 1990
CO2 REAGENT (340 NM)
K896258 · KHS
Sigma Chemical Co.
Chemistry · 106d
Cleared Feb 13, 1990
EOS IONIZED CALCIUM TEST CARD
K896316 · JFP
Eos Technology Corp.
Chemistry · 104d
Cleared Feb 13, 1990
LUTEINIZING HORMONE-EIA-XT
K896866 · CEP
In Vitro Diagnostics, Inc.
Chemistry · 69d
Cleared Feb 08, 1990
AMYLASE REAGENT
K896650 · JFJ
Sigma Chemical Co.
Chemistry · 76d
Cleared Feb 08, 1990
AMRESCO CREATININE REAGENT #4316100
K896686 · CGX
American Research Products Co.
Chemistry · 72d
Cleared Feb 08, 1990
ENZYMUN TEST R T3
K896900 · CDP
Boehringer Mannheim Corp.
Chemistry · 62d
Cleared Feb 08, 1990
ENZYMUN TEST R HCG
K896901 · JHI
Boehringer Mannheim Corp.
Chemistry · 62d
Cleared Feb 08, 1990
COULTER PHOSPHORUS REAGENT
K900215 · CEO
Coulter Corp.
Chemistry · 22d
Cleared Feb 08, 1990
COULTER ALP (ALK PHOS) REAGENT
K900216 · CJE
Coulter Corp.
Chemistry · 22d
Cleared Feb 01, 1990
AVL MODEL 995HB PH/BLOOD GAS ANALYZER
K895317 · CHL
Avl Scientific Corp.
Chemistry · 156d
Cleared Feb 01, 1990
CARBON DIOXIDE REAGENT
K896590 · KHS
Pointe Scientific, Inc.,
Chemistry · 72d
Cleared Jan 30, 1990
MODIFIED LH ENZYME IMMUNOASSAY TEST KIT
K896642 · CEP
Medix Biotech, Inc.
Chemistry · 67d
Cleared Jan 30, 1990
VITRO T4-EIA-XT
K896865 · KLI
In Vitro Diagnostics, Inc.
Chemistry · 55d
Cleared Jan 29, 1990
MODIFIED ELISA FOR CHLAMYDIA
K896032 · LJC
Fairleigh Dickinson Laboratories, Inc.
Chemistry · 105d
Cleared Jan 23, 1990
QS90 SMOOTH E ARTERIAL BLOOD SAMPLER
K896514 · GIM
Radiometer America, Inc.
Chemistry · 70d
Cleared Jan 19, 1990
CLP NORMAL LIPID CONTROL
K895862 · JJY
Creative Laboratory Products, Inc.
Chemistry · 108d