510(k) K051794
- Device
- GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS
- Applicant
- OFFICE OF THE SURGEON GENERAL, U.S. ARMY
- 510(k) number
- K051794
- Product code
- NVQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-08-16
- Date received
- 2005-07-01
- Regulation
- 866.3045
- Classification name
- Bacteriophage And Controls, B. Anthracis Lysis
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DIANE ULLMAN
- Address
- 1436 Porter St. Office Of Regulatory Affairs Fort Detrick MD US 21702 21702
FDA Registration Numbers#
- 1050190
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NVQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143592 | GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC | The Surgeon General, Department of the Army | 2015-04-16 |
Legacy Summary#
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FDA Review#
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