Cleared Traditional

ARCHITECT STAT CK-MB IMMUNOASSAY

K041596 · Fisher Diagnostics · Chemistry
Jul 2004
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K041596 is an FDA 510(k) clearance for the ARCHITECT STAT CK-MB IMMUNOASSAY, a Fluorometric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHX), submitted by Fisher Diagnostics (Middletown, US). The FDA issued a Cleared decision on July 21, 2004, 37 days after receiving the submission on June 14, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K041596 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2004
Decision Date July 21, 2004
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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