BACTEROIDES BILE ESCULIN AGAR— 510(k) K832955

Clearance details

Applicant

Bd Becton Dickinson Vacutainer Systems Preanalytic

Product code

Code JSI

Device class

Class 1

Regulation

21 CFR 866.2360

Advisory panel

Microbiology

Date received

1983-08-31

Decision date

1983-09-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Washington, DC, US

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• Z-1802-2013 — BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Bacteroides Bile Esculin Agar (BBE) is recommended as a primary isolation medium for the selection and presumptive identification of the B. fragilis group.Class II·Terminated·Becton Dickinson & Co.·20130606

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K832955.