Cleared Traditional

Tina-quant Transferrin ver.2 (urine application)

K182095 · Roche Diagnostics Operations (Rdo) · Immunology
Nov 2018
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K182095 is an FDA 510(k) clearance for the Tina-quant Transferrin ver.2 (urine application), a Transferrin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDG), submitted by Roche Diagnostics Operations (Rdo) (Indianapolos, US). The FDA issued a Cleared decision on November 5, 2018, 94 days after receiving the submission on August 3, 2018. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5880.

Submission Details

510(k) Number K182095 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2018
Decision Date November 05, 2018
Days to Decision 94 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DDG — Transferrin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5880

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