Cleared Traditional

BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial

K161306 · Becton Dickinson · Microbiology
Aug 2016
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K161306 is an FDA 510(k) clearance for the BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial, a System, Blood Culturing (Class I — General Controls, product code MDB), submitted by Becton Dickinson (Sparks, US). The FDA issued a Cleared decision on August 8, 2016, 90 days after receiving the submission on May 10, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number K161306 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2016
Decision Date August 08, 2016
Days to Decision 90 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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