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
10585–10608 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 05, 1983
ENCORE CHEMISTRY ANALYZER
K830641 · JJG
Baker Instructions Corp.
Chemistry · 35d
Cleared Apr 05, 1983
PHASE THYROXINE RADIOIMMUNOASSAY KIT
K830642 · CDX
Medical & Scientific Designs, Inc.
Chemistry · 35d
Cleared Apr 05, 1983
CREATINE KINASE REAGENT SET
K830672 · JHY
Sterling Biochemical, Inc.
Chemistry · 32d
Cleared Apr 05, 1983
FEKAL CON-TRATE SYSTEM
K830769 · KLI
Trend Scientific, Inc.
Chemistry · 25d
Cleared Mar 29, 1983
AUTO PREP
K830319 · JQW
Pm America, Inc.
Chemistry · 57d
Cleared Mar 29, 1983
FEB TEST
K830564 · CFM
Wako Chemicals USA, Inc.
Chemistry · 34d
Cleared Mar 29, 1983
BETA-COTE B-HCG PREGNANCY SCREENING SYS
K830695 · JHI
Bd Becton Dickinson Vacutainer...
Chemistry · 22d
Cleared Mar 25, 1983
CORNING 102 PRINTER
K830296 · JQP
Corning Medical & Scientific
Chemistry · 57d
Cleared Mar 24, 1983
KINETIC CREATININE
K830447 · CGX
American Monitor Corp.
Chemistry · 42d
Cleared Mar 24, 1983
BILIRUBIN STANDARD-LYOPHILIZED
K830469 · JIT
Dow Instruments & Reagents, Inc.
Chemistry · 37d
Cleared Mar 24, 1983
NOVA 8 IONIZED CALCIUM/PH ANALYZER
K830502 · JFP
Nova Biomedical Corp.
Chemistry · 36d
Cleared Mar 24, 1983
FLOW-PAC ALKALINE PHOSPHATE REAGENT SET
K830535 · CJF
Amresco, Inc.
Chemistry · 34d
Cleared Mar 24, 1983
FLOW-PAC ALBUMIN REAGENT
K830536 · CIX
Amresco, Inc.
Chemistry · 34d
Cleared Mar 24, 1983
FLOW-PAC CREATININE REAGENT SET
K830537 · CGX
Amresco, Inc.
Chemistry · 34d
Cleared Mar 24, 1983
FLOW-PAC TOTAL PROTEIN REAGENT SET
K830538 · CEK
Amresco, Inc.
Chemistry · 34d
Cleared Mar 24, 1983
AMRESCO UREA NITROGEN REAGENT SET
K830555 · CDQ
Amresco, Inc.
Chemistry · 29d
Cleared Mar 24, 1983
CREATININE
K830556 · CGX
Pointe Scientific, Inc.,
Chemistry · 29d
Cleared Mar 24, 1983
CORNING FERRITIN 125I RADIOIMMUNOASSAY
K830591 · DBF
Corning Medical & Scientific
Chemistry · 28d
Cleared Mar 24, 1983
QUIK-SEP IGM ISOLATION SYSTEM
K830606 · DFT
Isolab, Inc.
Chemistry · 27d
Cleared Mar 21, 1983
RAICHEM HDL-CHOLESTEROL REAGENT
K830207 · LBR
Reagents Applications, Inc.
Chemistry · 59d
Cleared Mar 17, 1983
RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E
K830357 · DGC
Clinetics Corp.
Chemistry · 42d
Cleared Mar 11, 1983
FERRITIN IMMUNORADIOMETRIC ASSAY KIT
K823829 · DFB
Bd Becton Dickinson Vacutainer...
Chemistry · 81d
Cleared Mar 10, 1983
NO-BOIL SOLID PHASE SIMUL TRAC B12
K822721 · CDD
Bd Becton Dickinson Vacutainer...
Chemistry · 184d
Cleared Mar 10, 1983
PHADEBAS & PHADEZYM RAST ALLERGEN DISCS
K830155 · DHB
Pharmacia, Inc.
Chemistry · 51d