BREATHTEK - UBIT UBT FOR H. PYLORI
FDA 510(k) clearance K014225 · decided 2002-01-17
Clearance details
- K-number
- K014225
- Device name
- BREATHTEK - UBIT UBT FOR H. PYLORI
- Applicant
- Meretek Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-12-26
- Decision date
- 2002-01-17
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- MSQ
- Device class
- 1
- Regulation number
- 866.3110
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Nashville, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro dia recall (Z-0003-2008) | Meretek Diagnostics, Inc. | 2007-10-04 |