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510(k) K972352

THE MERETEK UBT BREATH TEST FOR H.PYLORI by Meretek Diagnostics, Inc. — Product Code MSQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1997
Date Received
June 24, 1997
Clearance Type
Traditional
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

Other clearances by Meretek Diagnostics, Inc.

  • K014225 — BREATHTEK - UBIT UBT FOR H. PYLORI (January 17, 2002)
  • K952220 — MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT (September 17, 1996)

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