Cleared Traditional

TINA-QUANT IGG GEN.2

K050113 · Roche Diagnostics Corp. · Immunology
Feb 2005
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K050113 is an FDA 510(k) clearance for the TINA-QUANT IGG GEN.2, a Igg, Antigen, Antiserum, Control (Class II — Special Controls, product code DEW), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on February 8, 2005, 21 days after receiving the submission on January 18, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K050113 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2005
Decision Date February 08, 2005
Days to Decision 21 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DEW — Igg, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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