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510(k) K143592

GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC by The Surgeon General, Department of the Army — Product Code NVQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2015
Date Received
December 18, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bacteriophage And Controls, B. Anthracis Lysis
Device Class
Class II
Regulation Number
866.3045
Review Panel
MI
Submission Type

A gamma phage lysis assay intended for the identification of bacillus anthracis from non-hemolytic, aerobic gram positive colonies isolated from sheep blood agar. To aid in the laboratory identification of bacillus anthracis culture growth by lysis with a specific bacteriophage.

Other clearances by The Surgeon General, Department of the Army

  • K140387 — Burn Resuscitation Decision Support System - Clinical (BRDSS-C) (December 23, 2014)

Other clearances for product code NVQ

  • K051794 — GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS (August 16, 2005)