The following data is part of a premarket notification filed by Meretek Diagnostics, Inc. with the FDA for Breathtek - Ubit Ubt For H. Pylori.
| Device ID | K014225 |
| 510k Number | K014225 |
| Device Name: | BREATHTEK - UBIT UBT FOR H. PYLORI |
| Classification | Test, Urea (breath Or Blood) |
| Applicant | MERETEK DIAGNOSTICS, INC. 618 GRASSMERE PARK DRIVE, SUITE 20 Nashville, TN 37211 |
| Contact | Denise E Spellman |
| Correspondent | Denise E Spellman MERETEK DIAGNOSTICS, INC. 618 GRASSMERE PARK DRIVE, 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 | 2001-12-26 |
| Decision Date | 2002-01-17 |
| Summary: | summary |