510(k) K143592
K143592 is an FDA 510(k) premarket notification submitted by The Surgeon General, Department of the Army for the device "GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC". The FDA issued a decision of Substantially Equivalent on April 16, 2015. The device falls under product code NVQ (Bacteriophage And Controls, B. Anthracis Lysis), a Class II device regulated under 21 CFR 866.3045. The Surgeon General, Department of the Army has at least 1 other 510(k) clearance on record.
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.