510(k) K051794
K051794 is an FDA 510(k) premarket notification submitted by Office of the Surgeon General, U.S. Army for the device "GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS". The FDA issued a decision of Substantially Equivalent on August 16, 2005. The device falls under product code NVQ (Bacteriophage And Controls, B. Anthracis Lysis), a Class II device regulated under 21 CFR 866.3045.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2005
- Date Received
- July 1, 2005
- Clearance Type
- Traditional
- 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.