Cleared Traditional

CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305

K930359 · Helena Laboratories · Chemistry
Apr 1993
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K930359 is an FDA 510(k) clearance for the CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305, a Chromatographic Separation, Cpk Isoenzymes (Class II — Special Controls, product code JHT), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on April 12, 1993, 76 days after receiving the submission on January 26, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K930359 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1993
Decision Date April 12, 1993
Days to Decision 76 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JHT — Chromatographic Separation, Cpk Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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