The following data is part of a premarket notification filed by Office Of The Surgeon General, U.s. Army with the FDA for Gamma Phage Lysis Assay For The Identification Of Bacillus Anthracis.
| Device ID | K051794 |
| 510k Number | K051794 |
| Device Name: | GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS |
| Classification | Bacteriophage And Controls, B. Anthracis Lysis |
| Applicant | OFFICE OF THE SURGEON GENERAL, U.S. ARMY 1436 PORTER STREET OFFICE OF REGULATORY AFFAIRS Fort Detrick, MD 21702 |
| Contact | Diane Ullman |
| Correspondent | Julie Villaneuva Centers For Disease Control Nad Prevention 1600 Clifton RD NE MS H24-11 Atlanta, GA 30329 |
| Product Code | NVQ |
| CFR Regulation Number | 866.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-01 |
| Decision Date | 2005-08-16 |