Cleared Traditional

K050944 - K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET
(FDA 510(k) Clearance)

K050944 · Kamiya Biomedical Co. · Immunology

Dec 2005

Decision

253d

Days

Class 2

Risk

K050944 is an FDA 510(k) clearance for the K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET, a Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DBF), submitted by Kamiya Biomedical Co. (Tukwila, US). The FDA issued a Cleared decision on December 23, 2005, 253 days after receiving the submission on April 14, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5340.

Submission Details

510(k) Number	K050944 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 2005
Decision Date	December 23, 2005
Days to Decision	253 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF