Cleared Traditional

TINA-QUANT ALBUMIN GEN.2

K113072 · Roche Diagnostics Operations · Toxicology
May 2012
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K113072 is an FDA 510(k) clearance for the TINA-QUANT ALBUMIN GEN.2, a Albumin, Antigen, Antiserum, Control (Class II — Special Controls, product code DCF), submitted by Roche Diagnostics Operations (Indianpolis, US). The FDA issued a Cleared decision on May 14, 2012, 210 days after receiving the submission on October 17, 2011. This device falls under the Toxicology review panel. Regulated under 21 CFR 866.5040.

Submission Details

510(k) Number K113072 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2011
Decision Date May 14, 2012
Days to Decision 210 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DCF — Albumin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5040

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