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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
13009–13032 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared May 10, 1977
BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR.
K770458 · CIG
Icn Pharmaceuticals, Inc.
Chemistry · 63d
Cleared May 09, 1977
SMAC SYSTEM
K770508 · JCC
Mid Tech, Inc.
Chemistry · 53d
Cleared May 06, 1977
IN VITRO DIAGNOSTIC REAGENTS
K770506 · JJC
Norwood Scientific Associates, Inc.
Chemistry · 51d
Cleared May 03, 1977
URINALYSIS PROFICIENCY
K770390 · JJW
Miles Laboratories, Inc.
Chemistry · 64d
Cleared May 03, 1977
CALCIUM PROCEDURE, TEKPOINT DIRECT
K770449 · CIC
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared May 03, 1977
CHLORIDE PROCEDURE, TEKPOINT DIRECT
K770450 · CHJ
Icn Pharmaceuticals, Inc.
Chemistry · 56d