510(k) K014225
K014225 is an FDA 510(k) premarket notification submitted by Meretek Diagnostics, Inc. for the device "BREATHTEK - UBIT UBT FOR H. PYLORI". The FDA issued a decision of Substantially Equivalent on January 17, 2002. The device falls under product code MSQ (Test, Urea (Breath Or Blood)), a Class I device regulated under 21 CFR 866.3110. Meretek Diagnostics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2002
- Date Received
- December 26, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Urea (Breath Or Blood)
- Device Class
- Class I
- Regulation Number
- 866.3110
- Review Panel
- MI
- Submission Type