Cleared Traditional

TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II

K872063 · Hybritech, Inc. · Chemistry
Jun 1987
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K872063 is an FDA 510(k) clearance for the TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II, a Colorimetric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHY), submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on June 19, 1987, 22 days after receiving the submission on May 28, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K872063 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1987
Decision Date June 19, 1987
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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