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
12985–13008 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 24, 1977
UN, UV DELTA TEST ASSAY
K770654 · CDQ
Bd Becton Dickinson Vacutainer...
Chemistry · 79d
Cleared Jun 24, 1977
ANALYZER, CENTRIFUGAL, IL MULTISTAT III
K770660
Instrumentation Laboratory CO
Chemistry · 78d
Cleared Jun 17, 1977
DETER. OF PHOSPHOHEXOSE ISOMERASE
K770577 · KLJ
Sigma Chemical Co.
Chemistry · 81d
Cleared Jun 17, 1977
LDH ULTRAZYME PLUS
K770613 · CFJ
Harleco Diagnostics
Chemistry · 78d
Cleared Jun 17, 1977
REAGENT, CHLORIDE, COULTER
K770752 · CHJ
Coulter Electronics, Inc.
Chemistry · 53d
Cleared Jun 17, 1977
LIQUI SOL T4 RIA TEST KIT
K770918 · CDP
Damon Corp.
Chemistry · 29d
Cleared Jun 15, 1977
TUBES, HYDROLYSIS, CALIBRATED
K770605
Organon, Inc.
Chemistry · 76d
Cleared Jun 14, 1977
ANALYZER, SODIUM/POTASSIUM NOVA L
K770601 · JGS
Nova Biomedical Corp.
Chemistry · 76d
Cleared Jun 08, 1977
CHOLESTEROL REAGENT
K770483 · CHH
Smithkline Diagnostics, Inc.
Chemistry · 86d
Cleared Jun 08, 1977
QUANTI. COLORI. DET. OF SERUM IRON
K770495
Sigma Chemical Co.
Chemistry · 86d
Cleared Jun 08, 1977
CALCIUM/MAGNESIUM ANALYZER
K770570 · JFN
Beckman Instruments, Inc.
Chemistry · 75d
Cleared Jun 03, 1977
URINE TESTER, MODEL NO. 707
K770423 · EXR
Brother Scientific Products, Inc.
Chemistry · 88d
Cleared Jun 03, 1977
REAGENT SYSTEM 153-UV
K770519 · JKG
Sigma Chemical Co.
Chemistry · 77d
Cleared Jun 03, 1977
RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3
K770520 · CDP
Kallestad Laboratories, Inc.
Chemistry · 77d
Cleared Jun 03, 1977
CPK ISOENZYME CONTROL
K770555 · JJT
Bio-Reagents & Diagnostics, Inc.
Chemistry · 74d
Cleared Jun 03, 1977
URIC ACID TEST KIT
K770564 · CDH
Mallinckrodt Critical Care
Chemistry · 71d
Cleared Jun 02, 1977
TECHNICON SMA & AAII SYSTEMS
K770406 · CJE
Boehringer Laboratories
Chemistry · 91d
Cleared Jun 02, 1977
CENTRIFI CHEM CALCIUM REAGENT
K770460 · CIC
Union Carbide Corp.
Chemistry · 86d
Cleared Jun 02, 1977
RIA-120 AND ESTRIOL REAGENT SYSTEM
K770465 · CGI
Bd Becton Dickinson Vacutainer...
Chemistry · 84d
Cleared Jun 02, 1977
WORTHINGTON BUN
K770470 · CDW
Worthington Biochemical Corp.
Chemistry · 84d
Cleared Jun 02, 1977
MONITOR, PATIENT, MODEL PM-20N
K770736 · CHL
Cavitron Corp.
Chemistry · 42d
Cleared Jun 02, 1977
CHOLESTEROL REAGENT SET
K770998 · CHH
The Dow Chemical Co.
Chemistry
Cleared Jun 01, 1977
REAGENT SET, CHOLESTEROL, CAT NO. 4024
K770747 · CHH
American Monitor Corp.
Chemistry · 40d
Cleared Jun 01, 1977
TEST, FERROZINE IRON & IRON BINDING
K770748 · JMO
Hycel, Inc.
Chemistry · 40d