Cleared Traditional

TINA-QUANT ALBUMIN GEN 2

K101203 · Roche Diagnostics · Chemistry
Sep 2010
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K101203 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 (Indianapolos, US). The FDA issued a Cleared decision on September 10, 2010, 134 days after receiving the submission on April 29, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5040.

Submission Details

510(k) Number K101203 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2010
Decision Date September 10, 2010
Days to Decision 134 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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