Cleared Traditional

AMERLITE CK-MB ASSAY

K912766 · Amersham Corp. · Chemistry
Jul 1991
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K912766 is an FDA 510(k) clearance for the AMERLITE CK-MB ASSAY, a Colorimetric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHY), submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on July 17, 1991, 23 days after receiving the submission on June 24, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K912766 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 1991
Decision Date July 17, 1991
Days to Decision 23 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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