Cleared Traditional

K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR

K121232 · Kamiya Biomedical Company · Immunology

May 2012

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K121232 is an FDA 510(k) clearance for the K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR, a Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DBF), submitted by Kamiya Biomedical Company (Tukwila, US). The FDA issued a Cleared decision on May 24, 2012, 30 days after receiving the submission on April 24, 2012. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5340.

Submission Details

510(k) Number	K121232 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 2012
Decision Date	May 24, 2012
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF