Cleared Traditional

Teco Creatinine Enzymatic Reagent Kit

K161527 · Teco Diagnostics, Inc. · Chemistry
Jul 2017
Decision
414d
Days
Class 2
Risk

About This 510(k) Submission

K161527 is an FDA 510(k) clearance for the Teco Creatinine Enzymatic Reagent Kit, a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by Teco Diagnostics, Inc. (Anaheim, US). The FDA issued a Cleared decision on July 21, 2017, 414 days after receiving the submission on June 2, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K161527 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2016
Decision Date July 21, 2017
Days to Decision 414 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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