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
12241–12264 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 17, 1979
GLUCOSE REAGENT
K791685 · CGA
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
CO2 CUP REAGENT
K791686 · JFL
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
CO2 REFERENCE REAGENT
K791687 · JFL
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
ALKALINE BUFFER
K791688 · CGX
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
PICRIC SOLUTION
K791689 · CGX
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
CHOLORDE REAGENT
K791690 · JFS
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
SODIUM/POTASSIUM CONDITIONING SOLUTION
K791691 · JGS
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
SODIUM/POTASSIUM BUFFER SOLUTION
K791692 · CEM
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
CALIBRATOR I
K791693 · JIX
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
CALIBRATOR II
K791694 · JIX
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 04, 1979
GLUCOSE GOD-PAP TRINDER METHOD TEST KIT
K791066 · CGA
Fermco Biochemics, Inc.
Chemistry · 84d
Cleared Sep 04, 1979
TSH RIA KIT
K791217 · JLW
Antibodies, Inc.
Chemistry · 64d
Cleared Sep 04, 1979
DAC-CEL T4
K791231 · CDX
Burroughs Wellcome Co.
Chemistry · 64d
Cleared Sep 04, 1979
DAC-CEL T3
K791232 · CDP
Burroughs Wellcome Co.
Chemistry · 64d
Cleared Sep 04, 1979
ENZYMATIC REAGENT SET, 4X250 ML.
K791511 · CHH
Macomb Chemical Co.
Chemistry · 40d
Cleared Aug 28, 1979
MICROMEDIC APS2
K791324 · JQW
Micromedic Systems
Chemistry · 43d
Cleared Aug 16, 1979
MEDICOR QUALITY CONTROL BUFFER
K791287 · JJS
Medicor USA , Ltd.
Chemistry · 37d
Cleared Aug 16, 1979
CPK ISOENZYME CONTROL
K791299 · JJT
Electrophoresis Corp. of America
Chemistry · 31d
Cleared Aug 16, 1979
LDH ISOENZYME CONTROL
K791300 · JJT
Electrophoresis Corp. of America
Chemistry · 31d
Cleared Aug 16, 1979
MANUAL MICRO ELISA READER #2-530
K791302 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 37d
Cleared Aug 16, 1979
CATALOG #4-2520 CHLORIDOMETER CHLORIDE
K791312 · JIT
Buchler Instruments, Inc.
Chemistry · 36d
Cleared Aug 16, 1979
ARS, CHEMISTRY
K791313 · JJY
Mid Tech, Inc.
Chemistry · 35d
Cleared Aug 16, 1979
SPECTRO-SUR SET
K791315 · JIS
Helena Laboratories
Chemistry · 31d
Cleared Aug 16, 1979
T3 UPTAKE RADIOIMMUNOASSAY KIT
K791361 · KHQ
Technia Diagnostics , Ltd.
Chemistry · 27d