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510(k) K952220

MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT by Meretek Diagnostics, Inc. — Product Code LYR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1996
Date Received
May 11, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Helicobacter Pylori
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)
  • K972352 — THE MERETEK UBT BREATH TEST FOR H.PYLORI (October 29, 1997)

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  • K182559 — PREMIER Platinum HpSA PLUS (November 5, 2018)
  • K181464 — LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (August 31, 2018)
  • K181379 — H. PYLORI QUIK CHEK (August 21, 2018)
  • K181400 — H. PYLORI CHEK™ (August 21, 2018)
  • K161139 — LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (July 22, 2016)
  • K153661 — ImmunoCard STAT! HpSA (March 14, 2016)