Cleared Traditional

CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)

K112586 · Becton, Dickinson and Company (BD) · Microbiology
Oct 2011
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K112586 is an FDA 510(k) clearance for the CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM), a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Becton, Dickinson and Company (BD) (Sparks, US). The FDA issued a Cleared decision on October 18, 2011, 42 days after receiving the submission on September 6, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K112586 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2011
Decision Date October 18, 2011
Days to Decision 42 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JTN — Susceptibility Test Discs, Antimicrobial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1620

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