Cleared Traditional

ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR

K122599 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Oct 2012
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K122599 is an FDA 510(k) clearance for the ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR, a Myoglobin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDR), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on October 3, 2012, 37 days after receiving the submission on August 27, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5680.

Submission Details

510(k) Number K122599 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2012
Decision Date October 03, 2012
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DDR — Myoglobin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5680

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