The following data is part of a premarket notification filed by Advanced Medical Technology, Inc. with the FDA for Rapi - Staph.
| Device ID | K852997 |
| 510k Number | K852997 |
| Device Name: | RAPI - STAPH |
| Classification | Kit, Screening, Staphylococcus Aureus |
| Applicant | ADVANCED MEDICAL TECHNOLOGY, INC. SUITE 502, PERIMETER PARK 3351 WRIGHTSBORO, RD. Augusta, GA 30909 |
| Contact | David A Wall |
| Correspondent | David A Wall ADVANCED MEDICAL TECHNOLOGY, INC. SUITE 502, PERIMETER PARK 3351 WRIGHTSBORO, RD. Augusta, GA 30909 |
| Product Code | JWX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-15 |
| Decision Date | 1985-08-19 |