Cleared Traditional

TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM

K061683 · Roche Diagnostics Corp. · Chemistry
Jul 2006
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K061683 is an FDA 510(k) clearance for the TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM, a Myoglobin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDR), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on July 21, 2006, 36 days after receiving the submission on June 15, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5680.

Submission Details

510(k) Number K061683 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2006
Decision Date July 21, 2006
Days to Decision 36 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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