Cleared Traditional

ELECSYS CK-MB

K961501 · Boehringer Mannheim Corp. · Chemistry
Jun 1996
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K961501 is an FDA 510(k) clearance for the ELECSYS CK-MB, a U.v. Method, Cpk Isoenzymes (Class II — Special Controls, product code JHW), submitted by Boehringer Mannheim Corp. (Indianapolis,, US). The FDA issued a Cleared decision on June 11, 1996, 54 days after receiving the submission on April 18, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K961501 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 1996
Decision Date June 11, 1996
Days to Decision 54 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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