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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
11113–11136 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 26, 1982
CENTRIA PROLACTIN TEST SET
K813572 · CFT
Ventrex Laboratories, Inc.
Chemistry · 94d
Cleared Mar 26, 1982
FOLLICLE STIMULATING HORMONE KIT
K820358 · CGJ
Pcl-Ria, Inc.
Chemistry · 45d
Cleared Mar 26, 1982
SODIUM PYRUVATE (100MM)
K820495 · KIT
Dutchland Laboratories, Inc.
Chemistry · 31d
Cleared Mar 26, 1982
MEM NON-ESSENTIAL AMINO ACIDS (100X)
K820508 · KIT
Dutchland Laboratories, Inc.
Chemistry · 31d
Cleared Mar 26, 1982
158 BLOOD GAS ANALYZER
K820597 · CHL
Corning Medical & Scientific
Chemistry · 22d
Cleared Mar 25, 1982
FETAL-TEK CONTROL MATURE
K820319 · JJS
Helena Laboratories
Chemistry · 48d
Cleared Mar 25, 1982
LUTEINIZING HORMONE KIT
K820357 · CEP
Pcl-Ria, Inc.
Chemistry · 44d
Cleared Mar 25, 1982
CORNING 902 SODIUM POTASSIUM ANALYZER
K820629 · CFM
Corning Medical & Scientific
Chemistry · 17d
Cleared Mar 25, 1982
COLORIMETRIC URIC ACID REAGENT SET
K820632 · KNK
Biorent Diagnostic, Inc.
Chemistry · 17d
Cleared Mar 22, 1982
PHADEZYM ANALYZER
K813563 · JJQ
Pharmacia, Inc.
Chemistry · 90d
Cleared Mar 16, 1982
COAT-A-COUNT PROGESTERONE KIA KIT
K820534 · JLS
Diagnostic Products Corp.
Chemistry · 14d
Cleared Mar 16, 1982
THIOGLYCOLLATE W/INDICATOR
K820549 · JSG
American Laboratory Supply, Inc.
Chemistry · 14d
Cleared Mar 16, 1982
THIOGLYCOLLATE ENRICHED
K820563 · KZI
American Laboratory Supply, Inc.
Chemistry · 14d
Cleared Mar 15, 1982
CENTRIFREE MICROPARTITION SYSTEM
K820455 · JRL
Amicon, Inc.
Chemistry · 24d
Cleared Mar 15, 1982
CHORIO-QUANT
K820523 · JHI
Nuclear Medical Laboratories, Inc.
Chemistry · 17d
Cleared Mar 15, 1982
RAICHEM GPT (ALT) REAGENT
K820525 · CKA
Reagents Applications, Inc.
Chemistry · 17d
Cleared Mar 11, 1982
MIN-MOLECULE PTH BY RADIOIMMUNOASSAY
K820228 · CEW
Immuno Nuclear Corp.
Chemistry · 43d
Cleared Mar 11, 1982
ABBOTT LABORATORIES B-HCG EIA
K820271 · JHI
Abbott Laboratories
Chemistry · 37d
Cleared Mar 11, 1982
IMMOPHASE B HCG RADIOIMMUNOASSAY
K820321 · JHI
Corning Medical & Scientific
Chemistry · 34d
Cleared Mar 11, 1982
LIQUIZYME NA+/K+ REAGENT SET
K820395 · JGS
American Research Products Co.
Chemistry · 28d
Cleared Mar 11, 1982
4150 ALPHA AMINO ACID ANALYZER
K820415 · JJF
Lkb Instruments, Inc.
Chemistry · 27d
Cleared Mar 11, 1982
K.D. COLORIMETRIC BLOOD UREA N2 TEST
K820418 · JGZ
King Diagnostics, Inc.
Chemistry · 23d
Cleared Mar 11, 1982
IL 8060 DATA MANAGEMENT SYSTEM
K820427 · JQP
Instrumentation Laboratory CO
Chemistry · 22d
Cleared Mar 11, 1982
CHEMSTRIP UG
K820465 · CGA
Biodynamics Corp.
Chemistry · 17d