Cleared Traditional

BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)

K123903 · Becton, Dickinson & CO · Microbiology
May 2013
Decision
145d
Days
Class 1
Risk

About This 510(k) Submission

K123903 is an FDA 510(k) clearance for the BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic), a System, Blood Culturing (Class I — General Controls, product code MDB), submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on May 13, 2013, 145 days after receiving the submission on December 19, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number K123903 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2012
Decision Date May 13, 2013
Days to Decision 145 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MDB — System, Blood Culturing
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2560

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