The following data is part of a premarket notification filed by Bainbridge Laboratories, Inc. with the FDA for Pyloritrak.
| Device ID | K912215 |
| 510k Number | K912215 |
| Device Name: | PYLORITRAK |
| Classification | Helicobacter Pylori |
| Applicant | BAINBRIDGE LABORATORIES, INC. 7861 DAY RD. WEST Bainbridge Island, WA 98110 |
| Contact | Max Lyon |
| Correspondent | Max Lyon BAINBRIDGE LABORATORIES, INC. 7861 DAY RD. WEST Bainbridge Island, WA 98110 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-20 |
| Decision Date | 1991-10-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PYLORITRAK 74125962 1809874 Dead/Cancelled |
BAINBRIDGE SCIENCES, INC. 1990-12-24 |