Cleared Traditional

ARCHITECT STAT MYO IMMUNOASSAY

K042924 · Fisher Diagnostics · Chemistry
Jan 2005
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K042924 is an FDA 510(k) clearance for the ARCHITECT STAT MYO IMMUNOASSAY, a Myoglobin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDR), submitted by Fisher Diagnostics (Middletown, US). The FDA issued a Cleared decision on January 24, 2005, 94 days after receiving the submission on October 22, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5680.

Submission Details

510(k) Number K042924 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2004
Decision Date January 24, 2005
Days to Decision 94 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DDR — Myoglobin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5680

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