Cleared Special

ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2

K040431 · Roche Diagnostics Corp. · Immunology
Mar 2004
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K040431 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2, a Igm (mu Chain Specific), Antigen, Antiserum, Control (Class II — Special Controls, product code DAO), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on March 10, 2004, 20 days after receiving the submission on February 19, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K040431 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2004
Decision Date March 10, 2004
Days to Decision 20 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DAO — Igm (mu Chain Specific), Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5550

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