VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY— 510(k) K080931

Clearance details

Applicant

bioMerieux, Inc.

Product code

Code LLH

Device class

Class 1

Regulation

21 CFR 866.2660

Advisory panel

Microbiology

Date received

2008-04-02

Decision date

2008-06-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hazelwood, MO, US

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