BD MAX(TM) ENTERIC BACTERIAL PANEL; BD MAX(TM) INSTRUMENT— 510(k) K140111

Clearance details

Device name as filed

BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT

Applicant

Becton, Dickinson and Company

Product code

Code PCI

Device class

Class 2

Regulation

21 CFR 866.3990

Advisory panel

Microbiology

Date received

2014-01-15

Decision date

2014-05-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Sparks, MD, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140111.