Cleared Traditional

ADVIA? Chemistry Total Bilirubin_2 (TBIL_2)

K170065 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Mar 2017
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K170065 is an FDA 510(k) clearance for the ADVIA? Chemistry Total Bilirubin_2 (TBIL_2), a Enzymatic Method, Bilirubin (Class II — Special Controls, product code JFM), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on March 9, 2017, 59 days after receiving the submission on January 9, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K170065 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 2017
Decision Date March 09, 2017
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFM — Enzymatic Method, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

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