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510(k) K000316

MERETEK UBT_LITE BREATH TEST FOR H. PYLORI by Meretek — Product Code MSQ

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

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