510(k) K000316
K000316 is an FDA 510(k) premarket notification submitted by Meretek for the device "MERETEK UBT_LITE BREATH TEST FOR H. PYLORI". The FDA issued a decision of Substantially Equivalent on February 24, 2000. The device falls under product code MSQ (Test, Urea (Breath Or Blood)), a Class I device regulated under 21 CFR 866.3110.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 2000
- Date Received
- February 1, 2000
- 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