Cleared Traditional

LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH

K063838 · Thermo Electron OY · Chemistry
Sep 2007
Decision
275d
Days
Class 2
Risk

About This 510(k) Submission

K063838 is an FDA 510(k) clearance for the LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH, a Lipoprotein, Low-density, Antigen, Antiserum, Control (Class II — Special Controls, product code DFC), submitted by Thermo Electron OY (Vantaa, FI). The FDA issued a Cleared decision on September 27, 2007, 275 days after receiving the submission on December 26, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5600.

Submission Details

510(k) Number K063838 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2006
Decision Date September 27, 2007
Days to Decision 275 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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