The following data is part of a premarket notification filed by American Micro Scan with the FDA for Neg Combo Breakpoint Panel Pos Combo.
| Device ID | K854278 |
| 510k Number | K854278 |
| Device Name: | NEG COMBO BREAKPOINT PANEL POS COMBO |
| Classification | Kit, Screening, Staphylococcus Aureus |
| Applicant | AMERICAN MICRO SCAN 855 57TH. ST. SUITE G Sacramento, CA 95819 |
| Contact | Krista L Underwood |
| Correspondent | Krista L Underwood AMERICAN MICRO SCAN 855 57TH. ST. SUITE G Sacramento, CA 95819 |
| Product Code | JWX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-24 |
| Decision Date | 1986-03-04 |