BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY— 510(k) K000884

Name: FDA 510(k) clearance K000884
Creator: U.S. Food and Drug Administration
Published: 2001-01-19

Substantially Equivalent

Becton Dickinson Biosciences

FDA 510(k) clearance K000884 for BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY, Substantially Equivalent on 2001-01-19. Applicant: Becton Dickinson Biosciences. Device class: 1.

Clearance details

Applicant: Becton Dickinson Biosciences
Product code: Code NDZ
Device class: Class 1
Regulation: 21 CFR 866.3370
Advisory panel: Microbiology
Date received: 2000-03-20
Decision date: 2001-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparks, MD, US

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