K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR— 510(k) K121232

Name: FDA 510(k) clearance K121232
Creator: U.S. Food and Drug Administration
Published: 2012-05-24

Substantially Equivalent

Kamiya Biomedical Company

FDA 510(k) clearance K121232 for K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR, Substantially Equivalent on 2012-05-24. Applicant: Kamiya Biomedical Company. Device class: 2.

Clearance details

Applicant: Kamiya Biomedical Company
Product code: Code DBF
Device class: Class 2
Regulation: 21 CFR 866.5340
Advisory panel: Immunology
Date received: 2012-04-24
Decision date: 2012-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tukwila, WA, US

Download summary PDF View on FDA.gov ↗

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