Cleared Traditional

STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY

K873171 · American Dade · Chemistry
Sep 1987
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K873171 is an FDA 510(k) clearance for the STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY, a Fluorometric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHX), submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on September 29, 1987, 49 days after receiving the submission on August 11, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K873171 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1987
Decision Date September 29, 1987
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JHX — Fluorometric Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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