Cleared Traditional

LABELLING CHANGES TO IMPRES-MB-X

K903508 · Intl. Immunoassay Laboratories, Inc. · Chemistry
Sep 1990
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K903508 is an FDA 510(k) clearance for the LABELLING CHANGES TO IMPRES-MB-X, a U.v. Method, Cpk Isoenzymes (Class II — Special Controls, product code JHW), submitted by Intl. Immunoassay Laboratories, Inc. (Santa Clara, US). The FDA issued a Cleared decision on September 7, 1990, 38 days after receiving the submission on July 31, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K903508 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 1990
Decision Date September 07, 1990
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JHW — U.v. Method, Cpk Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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