BACTEC FUNGAL MEDIUM— 510(k) K954923

Name: FDA 510(k) clearance K954923
Creator: U.S. Food and Drug Administration
Published: 1996-11-21

Substantially Equivalent

Becton Dickinson Diagnostic Instrument Systems

FDA 510(k) clearance K954923 for BACTEC FUNGAL MEDIUM, Substantially Equivalent on 1996-11-21. Applicant: Becton Dickinson Diagnostic Instrument Systems. Device class: 1.

Clearance details

Applicant: Becton Dickinson Diagnostic Instrument Systems
Product code: Code JTA
Device class: Class 1
Regulation: 21 CFR 866.2560
Advisory panel: Microbiology
Date received: 1995-10-26
Decision date: 1996-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparks, MD, US

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