Panels › Microbiology › Product code MSQ · Class 1
Test, Urea (Breath Or Blood)
Regulation 866.3110
0510(k)s in 12 months (17 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in MSQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Exalenz Bioscience , Ltd. | 5 | 1 |
| Meretek Diagnostics, Inc. | 2 | 1 |
| Meridian Bioscience Israel , Ltd. | 3 | 0 |
| Otsuka Pharmaceutical Co., Ltd. | 2 | 0 |
| Alimenterics, Inc. | 1 | 0 |
| Hema Metrics, LLC | 1 | 0 |
| Meretek | 1 | 0 |
| Metabolic Solutions, Inc. | 1 | 0 |
| Oridion Medical 1987 , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 19, 2022 | K221896 | BreathID Hp System Meridian Bioscience Israel , Ltd., IL | MSQ |
| Nov 10, 2022 | K223185 | BreathID® Smart System Meridian Bioscience Israel , Ltd., IL | MSQ |
| Jun 23, 2022 | K220494 | BreathID Hp Lab System, BreathID Smart System Meridian Bioscience Israel , Ltd., IL | MSQ |
| Feb 6, 2020 | K193610 | BreathID Smart System Exalenz Bioscience , Ltd., IL | MSQ |
| Mar 8, 2018 | K173777 | BreathID Hp Lab System Exalenz Bioscience , Ltd., IL | MSQ |
| Mar 8, 2018 | K173772 | BreathID Hp System Exalenz Bioscience , Ltd., IL | MSQ |
| Oct 31, 2016 | K162150 | BreathID Hp Lab System Exalenz Bioscience , Ltd., IL | MSQ |
| May 22, 2013 | K130524 | BREATHID HP SYSTEM Exalenz Bioscience , Ltd. | MSQ |
| Sep 29, 2010 | K093834 | CRIT-LINE ANEMIA MANAGEMENT SOFTWARE Hema Metrics, LLC | MSQ |
| Mar 9, 2010 | K092817 | POC-AS10 AUTO SAMPLER Otsuka Pharmaceutical Co., Ltd. | MSQ |
| Jul 15, 2004 | K041148 | POCONE INFRARED SPECTROPHOTOMETER Otsuka Pharmaceutical Co., Ltd. | MSQ |
| Jan 17, 2002 | K014225 | BREATHTEK - UBIT UBT FOR H. PYLORI Meretek Diagnostics, Inc. | MSQ |
| Jul 9, 2001 | K011668 | VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI Oridion Medical 1987 , Ltd., IL | MSQ |
| Feb 24, 2000 | K000316 | MERETEK UBT_LITE BREATH TEST FOR H. PYLORI Meretek | MSQ |
| Sep 24, 1999 | K990931 | EZ-HBT HELICOBACTER BLOOD TEST Metabolic Solutions, Inc. | MSQ |
| Feb 26, 1998 | K973000 | ALIMENTERICS LARA (TM) BREATH TEST SYSTEM Alimenterics, Inc. | MSQ |
| Oct 29, 1997 | K972352 | THE MERETEK UBT BREATH TEST FOR H.PYLORI Meretek Diagnostics, Inc. | MSQ |
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