The following data is part of a premarket notification filed by American Micro Scan with the FDA for Autoscan W/a System.
| Device ID | K854448 |
| 510k Number | K854448 |
| Device Name: | AUTOSCAN W/A SYSTEM |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | AMERICAN MICRO SCAN 855 57TH. ST. SUITE G Sacramento, CA 95819 |
| Contact | Alice J O'connell |
| Correspondent | Alice J O'connell AMERICAN MICRO SCAN 855 57TH. ST. SUITE G Sacramento, CA 95819 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-05 |
| Decision Date | 1985-11-26 |