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510(k) K972352

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

K972352 is an FDA 510(k) premarket notification submitted by Meretek Diagnostics, Inc. for the device "THE MERETEK UBT BREATH TEST FOR H.PYLORI". The FDA issued a decision of Substantially Equivalent on October 29, 1997. 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
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)

Other clearances for product code MSQ

  • K221896 — BreathID Hp System (December 19, 2022)
  • K223185 — BreathID® Smart System (November 10, 2022)
  • K220494 — BreathID Hp Lab System, BreathID Smart System (June 23, 2022)
  • K193610 — BreathID Smart System (February 6, 2020)
  • K173772 — BreathID Hp System (March 8, 2018)
  • K173777 — BreathID Hp Lab System (March 8, 2018)
  • K162150 — BreathID Hp Lab System (October 31, 2016)
  • K130524 — BREATHID HP SYSTEM (May 22, 2013)
  • K093834 — CRIT-LINE ANEMIA MANAGEMENT SOFTWARE (September 29, 2010)
  • K092817 — POC-AS10 AUTO SAMPLER (March 9, 2010)

FDA data resources