GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC

Bacteriophage And Controls, B. Anthracis Lysis

THE SURGEON GENERAL, DEPARTMENT OF THE ARMY

The following data is part of a premarket notification filed by The Surgeon General, Department Of The Army with the FDA for Gamma Phage Lysis Assay For The Identification Of Bacillus Anthrac.

Pre-market Notification Details

Device IDK143592
510k NumberK143592
Device Name:GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC
ClassificationBacteriophage And Controls, B. Anthracis Lysis
Applicant THE SURGEON GENERAL, DEPARTMENT OF THE ARMY 1430 VETERANS DRIVE Fort Detrick,  MD  21702 -5009
ContactKenneth A. Bertram
CorrespondentKenneth A. Bertram
THE SURGEON GENERAL, DEPARTMENT OF THE ARMY 1430 VETERANS DRIVE Fort Detrick,  MD  21702 -5009
Product CodeNVQ  
CFR Regulation Number866.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-18
Decision Date2015-04-16
Summary:summary

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