Home / 510(k) Clearances / K014225

510(k) K014225

BREATHTEK - UBIT UBT FOR H. PYLORI by Meretek Diagnostics, Inc. — Product Code MSQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2002
Date Received
December 26, 2001
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

Other clearances by Meretek Diagnostics, Inc.

  • K972352 — THE MERETEK UBT BREATH TEST FOR H.PYLORI (October 29, 1997)
  • 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)
  • K173777 — BreathID Hp Lab System (March 8, 2018)
  • K173772 — BreathID Hp 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)