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510(k) K223185

BreathID® Smart System by Meridian Bioscience Israel , Ltd. — Product Code MSQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2022
Date Received
October 12, 2022
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 Meridian Bioscience Israel , Ltd.

  • K221896 — BreathID Hp System (December 19, 2022)
  • K220494 — BreathID Hp Lab System, BreathID Smart System (June 23, 2022)

Other clearances for product code MSQ

  • K221896 — BreathID Hp System (December 19, 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)
  • K041148 — POCONE INFRARED SPECTROPHOTOMETER (July 15, 2004)