MSQ · Class I · 21 CFR 866.3110

FDA Product Code MSQ: Test, Urea (breath Or Blood)

Leading manufacturers include Exalenz Bioscience , Ltd., Meridian Bioscience Israel , Ltd. and Meretek Diagnostics, Inc..

17
Total
17
Cleared
109d
Avg days
1997
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Test, Urea (breath Or Blood) Devices (Product Code MSQ)

17 devices
1–17 of 17
Cleared Dec 19, 2022
BreathID Hp System
K221896
Meridian Bioscience Israel , Ltd.
Microbiology · 172d
Cleared Nov 10, 2022
BreathID® Smart System
K223185
Meridian Bioscience Israel , Ltd.
Microbiology · 29d
Cleared Jun 23, 2022
BreathID Hp Lab System, BreathID Smart System
K220494
Meridian Bioscience Israel , Ltd.
Microbiology · 121d
Cleared Feb 06, 2020
BreathID Smart System
K193610
Exalenz Bioscience , Ltd.
Microbiology · 42d
Cleared Mar 08, 2018
BreathID Hp System
K173772
Exalenz Bioscience , Ltd.
Microbiology · 86d
Cleared Mar 08, 2018
BreathID Hp Lab System
K173777
Exalenz Bioscience , Ltd.
Microbiology · 86d
Cleared Oct 31, 2016
BreathID Hp Lab System
K162150
Exalenz Bioscience , Ltd.
Microbiology · 90d
Cleared May 22, 2013
BREATHID HP SYSTEM
K130524
Exalenz Bioscience , Ltd.
Microbiology · 83d
Cleared Sep 29, 2010
CRIT-LINE ANEMIA MANAGEMENT SOFTWARE
K093834
Hema Metrics, LLC
Microbiology · 289d
Cleared Mar 09, 2010
POC-AS10 AUTO SAMPLER
K092817
Otsuka Pharmaceutical Co., Ltd.
Microbiology · 176d
Cleared Jul 15, 2004
POCONE INFRARED SPECTROPHOTOMETER
K041148
Otsuka Pharmaceutical Co., Ltd.
Microbiology · 73d
Cleared Jan 17, 2002
BREATHTEK - UBIT UBT FOR H. PYLORI
K014225
Meretek Diagnostics, Inc.
Microbiology · 22d
Cleared Jul 09, 2001
VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI
K011668
Oridion Medical 1987 , Ltd.
Microbiology · 53d
Cleared Feb 24, 2000
MERETEK UBT_LITE BREATH TEST FOR H. PYLORI
K000316
Meretek
Microbiology · 23d
Cleared Sep 24, 1999
EZ-HBT HELICOBACTER BLOOD TEST
K990931
Metabolic Solutions, Inc.
Microbiology · 189d
Cleared Feb 26, 1998
ALIMENTERICS LARA (TM) BREATH TEST SYSTEM
K973000
Alimenterics, Inc.
Microbiology · 198d
Cleared Oct 29, 1997
THE MERETEK UBT BREATH TEST FOR H.PYLORI
K972352
Meretek Diagnostics, Inc.
Microbiology · 127d

About Product Code MSQ - Regulatory Context

510(k) Submission Activity

17 total 510(k) submissions under product code MSQ since 1997, with 17 receiving FDA clearance (average review time: 109 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.