Cleared Traditional

ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR

K123046 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Dec 2012
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K123046 is an FDA 510(k) clearance for the ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR, a Lipoprotein, Low-density, Antigen, Antiserum, Control (Class II — Special Controls, product code DFC), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on December 20, 2012, 83 days after receiving the submission on September 28, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5600.

Submission Details

510(k) Number K123046 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2012
Decision Date December 20, 2012
Days to Decision 83 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

Similar Devices — DFC Lipoprotein, Low-density, Antigen, Antiserum, Control

All 41
Tina-quant Lipoprotein(a) Gen.2 Molarity
K241220 · Roche Diagnostics Operations · Jan 2025
Lp(a) Ultra
K211058 · SENTINEL CH. SpA · Dec 2022
Diazyme Lipoprotein (a) Assay
K180074 · Diazyme Laboratories, Inc. · Mar 2018
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160
K122722 · Roche Diagnostics · Nov 2012
DIAZYME LP(A) ASSAY
K082488 · General Atomics · Jan 2009
LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH
K063838 · Thermo Electron OY · Sep 2007