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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
10849–10872 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 14, 1982
ENZYMUNE SYSTEM I
K822465 · JJE
Icl Scientific
Chemistry · 29d
Cleared Sep 14, 1982
PSI TOTAL PROTEIN REAGENT
K822468 · CEK
Pointe Scientific, Inc.,
Chemistry · 28d
Cleared Sep 14, 1982
PSI CALCIUM REAGENT
K822469 · CIC
Pointe Scientific, Inc.,
Chemistry · 28d
Cleared Sep 14, 1982
PSI INORGANIC PHOSPHORUS
K822470 · CEO
Pointe Scientific, Inc.,
Chemistry · 28d
Cleared Sep 14, 1982
PSI ALBUMIN REAGENT
K822471 · CIX
Pointe Scientific, Inc.,
Chemistry · 28d
Cleared Sep 14, 1982
CHOLESTEROL STANDARD #65077
K822474 · JIS
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Sep 14, 1982
TOTAL PROTEIN STANDARD, #65074
K822475 · JIT
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Sep 14, 1982
PHOSPHOROUS STANDARD #65073
K822476 · JIS
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Sep 14, 1982
ALBUMIN STANDARD, #65070
K822478 · JIT
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Sep 14, 1982
BILIRUBIN CALIBRATOR #65071
K822479 · JIT
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Sep 14, 1982
B-HCG RADIOIMMUNOASSAY KIT
K822515 · JHI
Bioclinical Group
Chemistry · 25d
Cleared Sep 13, 1982
LH (125I) RADIOIMMUNOASSAY
K822288 · CEP
Corning Medical & Scientific
Chemistry · 45d
Cleared Sep 13, 1982
LEECO T4 QUANT DIAGNOSTICS TEST KIT
K822399 · CDX
Leeco Diagnostics, Inc.
Chemistry · 34d
Cleared Sep 02, 1982
CONTROL DIAGNOSTICS PLATELET CONTROL
K821851 · KRY
Immunogenetics
Chemistry · 71d
Cleared Sep 02, 1982
HCG BETA RIA KIT
K822152 · JHI
Clinetics Corp.
Chemistry · 41d
Cleared Sep 02, 1982
DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI
K822298 · JFH
Nuclear Medical Laboratories, Inc.
Chemistry · 30d
Cleared Sep 02, 1982
ULTRACHEM BUN-UV, 65080 & 65081
K822323 · CDW
Harleco Diagnostics
Chemistry · 30d
Cleared Sep 02, 1982
BILIRUBIN CALIBRATORS
K822334 · JIT
Gilford Diagnostics
Chemistry · 29d
Cleared Sep 02, 1982
B-HCG
K822343 · JHI
Diagnostic Products Corp.
Chemistry · 28d
Cleared Sep 02, 1982
VAST VENTREX RAST ALLERGEN DISCS
K822442 · DGC
Ventrex Laboratories, Inc.
Chemistry · 17d
Cleared Aug 27, 1982
STIRRING ASSEMBLY FOR DIGISPEC X SPECTRO
K822050 · JJQ
Helena Laboratories
Chemistry · 45d
Cleared Aug 27, 1982
CAVRO IQ-190 SAMPLE PROCESSOR
K822208 · JQW
Cavro Scientific Instruments, Inc.
Chemistry · 35d
Cleared Aug 27, 1982
QUANTIMUNE HTSH IRMA
K822291 · JLW
Bio-Rad
Chemistry · 25d
Cleared Aug 27, 1982
RAICHEM LDH-L REAGENT
K822312 · CFJ
Reagents Applications, Inc.
Chemistry · 24d