Cleared Traditional

MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB

K901450 · Intl. Immunoassay Laboratories, Inc. · Chemistry
May 1990
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K901450 is an FDA 510(k) clearance for the MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB, a Chromatographic Separation, Cpk Isoenzymes (Class II — Special Controls, product code JHT), submitted by Intl. Immunoassay Laboratories, Inc. (Santa Clara, US). The FDA issued a Cleared decision on May 15, 1990, 48 days after receiving the submission on March 28, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K901450 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 1990
Decision Date May 15, 1990
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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