Cleared Traditional

SPIFE CK KIT, MODEL 3332, 3333

K022757 · Helena Laboratories · Chemistry
Oct 2002
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K022757 is an FDA 510(k) clearance for the SPIFE CK KIT, MODEL 3332, 3333, a Colorimetric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHY), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on October 11, 2002, 52 days after receiving the submission on August 20, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K022757 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 2002
Decision Date October 11, 2002
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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