Cleared Traditional

SENTINEL CERULOPLASMIN

K051456 · Sentinel Ch. Srl · Immunology

Oct 2005

Decision

141d

Days

Class 2

Risk

About This 510(k) Submission

K051456 is an FDA 510(k) clearance for the SENTINEL CERULOPLASMIN, a Indirect Copper Assay, Ceruloplasmin (Class II — Special Controls, product code JFR), submitted by Sentinel Ch. Srl (Milano, IT). The FDA issued a Cleared decision on October 21, 2005, 141 days after receiving the submission on June 2, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5210.

Submission Details

510(k) Number	K051456 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 2005
Decision Date	October 21, 2005
Days to Decision	141 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF