Cleared Traditional

Tina-quant Lipoprotein(a) Gen.2 Molarity

K241220 · Roche Diagnostics Operations · Chemistry
Jan 2025
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K241220 is an FDA 510(k) clearance for the Tina-quant Lipoprotein(a) Gen.2 Molarity, a Lipoprotein, Low-density, Antigen, Antiserum, Control (Class II — Special Controls, product code DFC), submitted by Roche Diagnostics Operations (Indianapolos, US). The FDA issued a Cleared decision on January 24, 2025, 268 days after receiving the submission on May 1, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5600.

Submission Details

510(k) Number K241220 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2024
Decision Date January 24, 2025
Days to Decision 268 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DFC — Lipoprotein, Low-density, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5600

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