510(k) K143592
- Device
- GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC
- Applicant
- THE SURGEON GENERAL, DEPARTMENT OF THE ARMY
- 510(k) number
- K143592
- Product code
- NVQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-16
- Date received
- 2014-12-18
- Regulation
- 866.3045
- Classification name
- Bacteriophage And Controls, B. Anthracis Lysis
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kenneth A. Bertram
- Address
- 1430 Veterans Dr. Fort Detrick MD US 21702 21702
FDA Registration Numbers#
- 1050190
Source Documents#
Other 510(k) Records For Product Code NVQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K051794 | GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS | Office of the Surgeon General, U.S. Army | 2005-08-16 |
Legacy Summary#
summary
FDA Review#
Decision Summary