The following data is part of a premarket notification filed by Advantage Diagnostics Corp with the FDA for Advance Diagnostics Disposable Eyecup.
| Device ID | K881369 |
| 510k Number | K881369 |
| Device Name: | ADVANCE DIAGNOSTICS DISPOSABLE EYECUP |
| Classification | Cup, Eye |
| Applicant | ADVANTAGE DIAGNOSTICS CORP P.O. BOX 12428 Tucson, AZ 85732 |
| Contact | Dan Misenhimer |
| Correspondent | Dan Misenhimer ADVANTAGE DIAGNOSTICS CORP P.O. BOX 12428 Tucson, AZ 85732 |
| Product Code | LXQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-01 |
| Decision Date | 1988-05-13 |