Cleared Traditional

MYDAS(TM)-MB2/MYDAS(TM)-MB

K913380 · Intl. Immunoassay Laboratories, Inc. · Chemistry
Apr 1992
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K913380 is an FDA 510(k) clearance for the MYDAS(TM)-MB2/MYDAS(TM)-MB, a Fluorometric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHX), submitted by Intl. Immunoassay Laboratories, Inc. (Santa Clara, US). The FDA issued a Cleared decision on April 22, 1992, 268 days after receiving the submission on July 29, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K913380 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1991
Decision Date April 22, 1992
Days to Decision 268 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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