The following data is part of a premarket notification filed by New Horizons Diagnostics Co. with the FDA for Pyloriscreen.
| Device ID | K925190 |
| 510k Number | K925190 |
| Device Name: | PYLORISCREEN |
| Classification | Helicobacter Pylori |
| Applicant | NEW HORIZONS DIAGNOSTICS CO. 9110 RED BRANCH RD. SUITE B Columbia, MD 21045 |
| Contact | Marjorie L Wier |
| Correspondent | Marjorie L Wier NEW HORIZONS DIAGNOSTICS CO. 9110 RED BRANCH RD. SUITE B Columbia, MD 21045 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-14 |
| Decision Date | 1993-03-23 |