GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS— 510(k) K051794

Name: FDA 510(k) clearance K051794
Creator: U.S. Food and Drug Administration
Published: 2005-08-16

Substantially Equivalent

Office of the Surgeon General, U.S. Army

FDA 510(k) clearance K051794 for GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS, Substantially Equivalent on 2005-08-16. Applicant: Office of the Surgeon General, U.S. Army. Device class: 2.

Clearance details

Applicant: Office of the Surgeon General, U.S. Army
Product code: Code NVQ
Device class: Class 2
Regulation: 21 CFR 866.3045
Advisory panel: Microbiology
Date received: 2005-07-01
Decision date: 2005-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Detrick, MD, US

Download summary PDF View on FDA.gov ↗

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