The following data is part of a premarket notification filed by The Surgeon General, Department Of The Army with the FDA for Gamma Phage Lysis Assay For The Identification Of Bacillus Anthrac.
| Device ID | K143592 |
| 510k Number | K143592 |
| Device Name: | GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC |
| Classification | Bacteriophage And Controls, B. Anthracis Lysis |
| Applicant | THE SURGEON GENERAL, DEPARTMENT OF THE ARMY 1430 VETERANS DRIVE Fort Detrick, MD 21702 -5009 |
| Contact | Kenneth A. Bertram |
| Correspondent | Kenneth A. Bertram THE SURGEON GENERAL, DEPARTMENT OF THE ARMY 1430 VETERANS DRIVE Fort Detrick, MD 21702 -5009 |
| Product Code | NVQ |
| CFR Regulation Number | 866.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-18 |
| Decision Date | 2015-04-16 |
| Summary: | summary |