Cleared Traditional

ARCHITECT STAT TROPONIN-I IMMUNOASSAY

K041192 · Fisher Diagnostics · Chemistry
Aug 2004
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K041192 is an FDA 510(k) clearance for the ARCHITECT STAT TROPONIN-I IMMUNOASSAY, a Immunoassay Method, Troponin Subunit (Class II — Special Controls, product code MMI), submitted by Fisher Diagnostics (Middletown, US). The FDA issued a Cleared decision on August 12, 2004, 98 days after receiving the submission on May 6, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K041192 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2004
Decision Date August 12, 2004
Days to Decision 98 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MMI — Immunoassay Method, Troponin Subunit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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