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
12433–12456 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 17, 1979
REAGENT SYSTEM, INORGANIC PHOSPHORUS
K781806 · CEO
Sigma Chemical Co.
Chemistry · 84d
Cleared Jan 17, 1979
GLUCOSE OXIDASE REAGENT
K781945 · CGA
Fermco Biochemics, Inc.
Chemistry · 57d
Cleared Jan 17, 1979
HEMESPEC
K782035 · JJQ
Helena Laboratories
Chemistry · 42d
Cleared Jan 17, 1979
PROCESSOR, K750 COMPUTER/DATA
K782052 · JQP
Kallestad Laboratories, Inc.
Chemistry · 41d
Cleared Jan 17, 1979
RIA KIT, NEONATAL T4
K782103 · CDX
Serono Laboratories, Inc.
Chemistry · 33d
Cleared Jan 10, 1979
BUN
K781782 · CDQ
Gilford Diagnostics
Chemistry · 83d
Cleared Jan 10, 1979
FERRITIN KIT
K781844 · JMG
Ria Products, Inc.
Chemistry · 70d
Cleared Jan 10, 1979
ASSAY SYSTEM, FERRITIN I KIT
K781888 · JMG
New England Nuclear
Chemistry · 64d
Cleared Jan 10, 1979
STAT KIT, MICROPROTEIN
K781897 · CEK
Pierce Chemical Co.
Chemistry · 58d
Cleared Jan 10, 1979
CALCITONIN 125
K781909 · JKR
Cambridge Nuclear Radiopharmaceutical
Chemistry · 57d
Cleared Jan 10, 1979
DATA MODULE
K781915 · KIE
Waters Assoc., Inc.
Chemistry · 57d
Cleared Jan 10, 1979
RIA KIT, GAMMADAB ESTRIOL
K781938 · CGI
Clinical Assays, Inc.
Chemistry · 51d
Cleared Jan 10, 1979
REAGENT KIT, TRIGLYCERIDES
K781939 · CDT
Beckman Instruments, Inc.
Chemistry · 51d
Cleared Jan 10, 1979
RIA KIT, FERRITIN SOLID PHASE
K781946 · JMG
Bd Becton Dickinson Vacutainer...
Chemistry · 50d
Cleared Jan 10, 1979
HORMONE KIT, PARATHYROID
K782010 · CEW
Nichols Institute Diagnostics
Chemistry · 40d
Cleared Jan 10, 1979
ANALYZER ABA-200
K782014 · JJE
Abbott Laboratories
Chemistry · 36d
Cleared Jan 03, 1979
AST
K781784 · CIT
Gilford Diagnostics
Chemistry · 76d
Cleared Jan 03, 1979
RIA, QUANTIMUNE E3
K781850 · CGI
Bio-Rad
Chemistry · 62d
Cleared Jan 03, 1979
RIA KIT, QUANTITOPE T3 UPTAKE
K781905 · KHQ
Kallestad Laboratories, Inc.
Chemistry · 51d
Cleared Jan 03, 1979
BILIRUBIN, DINGLE VALVE DPD
K781921 · CIG
Boehringer Mannheim Corp.
Chemistry · 51d
Cleared Jan 03, 1979
BLOOD GAS SYSTEM MODEL 168
K781968 · CHL
Corning Medical & Scientific
Chemistry · 40d
Cleared Jan 03, 1979
CHOLESTEROL REAGENT SUBSTRATE SET
K781970 · JHO
Corning Medical & Scientific
Chemistry · 40d
Cleared Jan 03, 1979
ACID REAGENT, URIC SINGLE VIAL
K781996 · CDO
Calbiochem-Behring Corp.
Chemistry · 35d
Cleared Dec 20, 1978
UROTRON
K781632 · JJQ
Boehringer Mannheim Corp.
Chemistry · 86d