Cleared Traditional

CREATINE KINASE REAGENT

K980012 · Ac Biochemicals, Inc. · Chemistry
Feb 1998
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K980012 is an FDA 510(k) clearance for the CREATINE KINASE REAGENT, a Fluorometric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHX), submitted by Ac Biochemicals, Inc. (Irvine, US). The FDA issued a Cleared decision on February 25, 1998, 54 days after receiving the submission on January 2, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K980012 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 1998
Decision Date February 25, 1998
Days to Decision 54 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JHX — Fluorometric Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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