Cleared Traditional

ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN

K083260 · Roche Diagnostics · Chemistry
Oct 2009
Decision
345d
Days
Class 2
Risk

About This 510(k) Submission

K083260 is an FDA 510(k) clearance for the ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN, a Myoglobin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDR), submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on October 16, 2009, 345 days after receiving the submission on November 5, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5680.

Submission Details

510(k) Number K083260 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2008
Decision Date October 16, 2009
Days to Decision 345 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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