FDA Product Code MSQ: Test, Urea (breath Or Blood)
Leading manufacturers include Exalenz Bioscience , Ltd. and Meridian Bioscience Israel , Ltd..
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
Cleared
Dec 19, 2022
BreathID Hp System
Meridian Bioscience Israel , Ltd.
Microbiology
172d
Cleared
Nov 10, 2022
BreathID® Smart System
Meridian Bioscience Israel , Ltd.
Microbiology
29d
Cleared
Jun 23, 2022
BreathID Hp Lab System, BreathID Smart System
Meridian Bioscience Israel , Ltd.
Microbiology
121d
Cleared
Feb 06, 2020
BreathID Smart System
Exalenz Bioscience , Ltd.
Microbiology
42d
Cleared
Mar 08, 2018
BreathID Hp System
Exalenz Bioscience , Ltd.
Microbiology
86d
Cleared
Mar 08, 2018
BreathID Hp Lab System
Exalenz Bioscience , Ltd.
Microbiology
86d
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.