Cleared Traditional

TINA-QUANT FERRITIN GEN. 4

K100538 · Roche Diagnostics · Immunology
Jun 2010
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K100538 is an FDA 510(k) clearance for the TINA-QUANT FERRITIN GEN. 4, a Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DBF), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on June 22, 2010, 117 days after receiving the submission on February 25, 2010. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5340.

Submission Details

510(k) Number K100538 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2010
Decision Date June 22, 2010
Days to Decision 117 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DBF — Ferritin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5340

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