The following data is part of a premarket notification filed by Saliva Diagnostic Systems, Inc. with the FDA for Stat-simple Pylori.
| Device ID | K980782 |
| 510k Number | K980782 |
| Device Name: | STAT-SIMPLE PYLORI |
| Classification | Helicobacter Pylori |
| Applicant | SALIVA DIAGNOSTIC SYSTEMS, INC. 11719 NE 95TH ST. Vancouver, WA 98682 |
| Contact | Paul D Slowey |
| Correspondent | Paul D Slowey SALIVA DIAGNOSTIC SYSTEMS, INC. 11719 NE 95TH ST. Vancouver, WA 98682 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-02 |
| Decision Date | 1998-08-05 |