Cleared Traditional

CREATININE (ENZYMATIC)

K070824 · Thermofisher Scientific OY · Chemistry
Dec 2007
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K070824 is an FDA 510(k) clearance for the CREATININE (ENZYMATIC), a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by Thermofisher Scientific OY (Vantaa, FI). The FDA issued a Cleared decision on December 3, 2007, 252 days after receiving the submission on March 26, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K070824 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2007
Decision Date December 03, 2007
Days to Decision 252 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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