Cleared Traditional

ENZYMATIC CREATININE ASSAY (265 SERIES)

K070383 · Diagnostic Chemicals , Ltd. · Chemistry
Jun 2007
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K070383 is an FDA 510(k) clearance for the ENZYMATIC CREATININE ASSAY (265 SERIES), a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on June 22, 2007, 133 days after receiving the submission on February 9, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K070383 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2007
Decision Date June 22, 2007
Days to Decision 133 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFY — Enzymatic Method, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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