The following data is part of a premarket notification filed by Meretek with the FDA for Meretek Ubt_lite Breath Test For H. Pylori.
| Device ID | K000316 |
| 510k Number | K000316 |
| Device Name: | MERETEK UBT_LITE BREATH TEST FOR H. PYLORI |
| Classification | Test, Urea (breath Or Blood) |
| Applicant | MERETEK 618 GRASSMERE PARK DR. SUITE 20 Nashville, TN 37211 |
| Contact | Kerry Bush |
| Correspondent | Kerry Bush MERETEK 618 GRASSMERE PARK DR. SUITE 20 Nashville, TN 37211 |
| Product Code | MSQ |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-01 |
| Decision Date | 2000-02-24 |