Cleared Traditional

MULTIGENT CREATININE (ENZYMATIC) ASSAY

K073634 · SENTINEL CH. SpA · Chemistry

Jun 2008

Decision

176d

Days

Class 2

Risk

About This 510(k) Submission

K073634 is an FDA 510(k) clearance for the MULTIGENT CREATININE (ENZYMATIC) ASSAY, a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by SENTINEL CH. SpA (Milano, IT). The FDA issued a Cleared decision on June 19, 2008, 176 days after receiving the submission on December 26, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number	K073634 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 2007
Decision Date	June 19, 2008
Days to Decision	176 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF