FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,231 results
12193–12216 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 27, 1979
PTH RIA 200
K791128 · CEW
Institut National Des Radioelements
Chemistry · 101d
Cleared Sep 27, 1979
VENTRE/SEP T3 TEST SET
K791588 · CDP
Ventrex Laboratories, Inc.
Chemistry · 41d
Cleared Sep 27, 1979
TOTAL ESTROGENS KIT BY RIA
K791651 · JMD
Radioassay Systems Laboratories, Inc.
Chemistry · 37d
Cleared Sep 27, 1979
ESTRADIOL KIT BY RIA
K791652 · CHP
Radioassay Systems Laboratories, Inc.
Chemistry · 37d
Cleared Sep 27, 1979
IMMUCHEM COVALENT COAT BINDING
K791662 · KHQ
Immuchem Corp.
Chemistry · 37d
Cleared Sep 27, 1979
IMMUCHEM COVALENT COAT SOLID PHASE ASSAY
K791664 · CDX
Immuchem Corp.
Chemistry · 37d
Cleared Sep 27, 1979
RSL'S ASSAY PROCEDURE QUANTITATION
K791728 · CGI
Radioassay Systems Laboratories, Inc.
Chemistry · 28d
Cleared Sep 27, 1979
SERUM 11-DESOXYCORTISOL I AS TRACER
K791740 · JKB
Radioassay Systems Laboratories, Inc.
Chemistry · 17d
Cleared Sep 27, 1979
URIC ACID REAGENT
K791754 · KNK
Gilford Diagnostics
Chemistry · 22d
Cleared Sep 27, 1979
GLUCOSE HEXOKINASE COIL REAGENT SYSTEM
K791760 · CFR
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Sep 27, 1979
CORALENT COAT 125I CORTISOL RADIOIMM.
K791835 · CGR
Radioassay Systems Laboratories, Inc.
Chemistry · 10d
Cleared Sep 24, 1979
ORTHO TSH RIA KIT
K791301 · JLW
Ortho Diagnostics, Inc.
Chemistry · 70d
Cleared Sep 24, 1979
BETA-CELL
K791607 · JSG
Biologics Intl., Inc.
Chemistry · 41d
Cleared Sep 24, 1979
COULTER ACCU-ZYME II ENZYMATIC REAGENT
K791640 · CDT
Coulter Electronics, Inc.
Chemistry · 34d
Cleared Sep 24, 1979
SGPT REAGENT SET MODIFICATION
K791641 · CKA
American Monitor Corp.
Chemistry · 34d
Cleared Sep 24, 1979
GLUCOSE OXIDASE REAGENT SET
K791669 · CGA
Macomb Chemical Co.
Chemistry · 27d
Cleared Sep 24, 1979
NADH OXIDATION, AST/SGOT
K791679 · CIT
American Monitor Corp.
Chemistry · 27d
Cleared Sep 24, 1979
CONTRO I
K791695 · JJY
Hi Chem, Inc.
Chemistry · 55d
Cleared Sep 24, 1979
CONTRO II
K791696 · JJY
Hi Chem, Inc.
Chemistry · 55d
Cleared Sep 24, 1979
INORGANIC PHOSPHORUS REAGENT
K791708 · CEO
Gilford Diagnostics
Chemistry · 27d
Cleared Sep 19, 1979
ANGIOTENSIN CONVERTING ENZYME ASSAY SYS
K791712 · KQN
Ventrex Laboratories, Inc.
Chemistry · 50d
Cleared Sep 17, 1979
DORN BLOOD CULTURE COLLECTION TUBE
K791303 · JKA
Wadley Institutes of Molecular Medici
Chemistry · 63d
Cleared Sep 17, 1979
VENTRE/SEP T4 TEST SET
K791368 · CDX
Ventrex Laboratories, Inc.
Chemistry · 54d
Cleared Sep 17, 1979
125I LEUTINIZING HORMONE RIA KIT
K791405 · CEP
Diagnostic Products Corp.
Chemistry · 48d