Cleared Traditional

COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160

K122722 · Roche Diagnostics · Chemistry
Nov 2012
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K122722 is an FDA 510(k) clearance for the COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160, a Lipoprotein, Low-density, Antigen, Antiserum, Control (Class II — Special Controls, product code DFC), submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on November 29, 2012, 85 days after receiving the submission on September 5, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5600.

Submission Details

510(k) Number K122722 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 2012
Decision Date November 29, 2012
Days to Decision 85 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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