Cleared Traditional

FERRITIN CONTROL - LEVEL 1, 2, 3

K946266 · Clinical Controls, Inc. · Immunology

Feb 1995

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K946266 is an FDA 510(k) clearance for the FERRITIN CONTROL - LEVEL 1, 2, 3, a Igg, Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DGD), submitted by Clinical Controls, Inc. (Grover Beach, US). The FDA issued a Cleared decision on February 10, 1995, 49 days after receiving the submission on December 23, 1994. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number	K946266 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 1994
Decision Date	February 10, 1995
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement