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
12793–12816 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 03, 1977
CPK COLOR TEST KIT
K771849 · CGS
Mallinckrodt Critical Care
Chemistry · 36d
Cleared Nov 03, 1977
DIR. QUANT. COLOR. DETERM. SERUM CREAT.
K771856 · CGX
Stanbio Laboratory
Chemistry · 35d
Cleared Nov 02, 1977
ALKALINE PHOSPHATASE
K771829 · CJE
Gamma Enterprises, Inc.
Chemistry · 42d
Cleared Nov 02, 1977
INORGANIC PHOSPHORUS
K771835 · CEO
Gamma Enterprises, Inc.
Chemistry · 42d
Cleared Nov 02, 1977
POTASSIUM
K771837 · CEM
Gamma Enterprises, Inc.
Chemistry · 42d
Cleared Nov 02, 1977
SODIUM
K771839 · JGS
Gamma Enterprises, Inc.
Chemistry · 42d
Cleared Nov 02, 1977
TEMP-TESTER
K771847 · GXB
Jablecki, Charles, Dr.
Chemistry · 35d
Cleared Nov 02, 1977
DISPOSABLE ELHCTRODE
K771893 · GYB
Chase Medical Services
Chemistry · 117d
Cleared Nov 02, 1977
ELECTROTHERM MODEL HT-1
K771994 · FLL
Electromedics, Inc.
Chemistry · 12d
Cleared Oct 28, 1977
ACA BILIRUBIN CALIBRATOR
K771798 · JJX
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 35d
Cleared Oct 28, 1977
PHOSPHORUS TEST KIT
K771848 · CEO
Mallinckrodt Critical Care
Chemistry · 30d
Cleared Oct 25, 1977
GAS CHROMA. ANALYSIS SYS., SERIES 37111
K771073
Varian Assoc., Inc.
Chemistry · 133d
Cleared Oct 25, 1977
CHEMCODE/CHEMTEK SYSTEM
K771496 · JJQ
Boehringer Mannheim Corp.
Chemistry · 81d
Cleared Oct 25, 1977
MULTISTAT III BICARBONATE TEST
K771507 · KHS
Instrumentation Laboratory CO
Chemistry · 81d
Cleared Oct 25, 1977
SPECTROPHOTOMETER ANALYSIS SYSTEM
K771637 · JJQ
Varian Assoc., Inc.
Chemistry · 60d
Cleared Oct 25, 1977
CHOLAR PRODU&T #17010
K771731 · CHH
Hi Chem, Inc.
Chemistry · 41d
Cleared Oct 25, 1977
9-WAY URINE TEST WITH ASCORBIC
K771755 · JIL
Miles Laboratories, Inc.
Chemistry · 39d
Cleared Oct 25, 1977
SERALUTE TSH (RIA)
K771767 · JLW
Miles Laboratories, Inc.
Chemistry · 36d
Cleared Oct 25, 1977
PONCEAU S CONCENTRATE
K771777 · HZO
Sigma Chemical Co.
Chemistry · 35d
Cleared Oct 25, 1977
ACA TRIGLYCERIDE CALIBRATOR
K771797 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Oct 25, 1977
ACA GLUTAMYL TRANSFERASE
K771800 · JJT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Oct 25, 1977
ACA CARBON DIOXIDE CALIBRATOR
K771801 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Oct 25, 1977
ACA IRON CALIBRATOR
K771802 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Oct 25, 1977
ACA PHOSPHORUS CALIBRATOR
K771803 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d