Cleared Traditional

HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT

K992148 · Morax · Chemistry
Dec 1999
Decision
188d
Days
Class 2
Risk

About This 510(k) Submission

K992148 is an FDA 510(k) clearance for the HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Morax (Chelsea, US). The FDA issued a Cleared decision on December 29, 1999, 188 days after receiving the submission on June 24, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K992148 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 1999
Decision Date December 29, 1999
Days to Decision 188 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CGS — Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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