Product code MSQ
- Device name
- Test, Urea (Breath Or Blood)
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3110
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221896 | BreathID Hp System | Meridian Bioscience Israel , Ltd. | 2022-12-19 |
| K223185 | BreathID® Smart System | Meridian Bioscience Israel , Ltd. | 2022-11-10 |
| K220494 | BreathID Hp Lab System, BreathID Smart System | Meridian Bioscience Israel , Ltd. | 2022-06-23 |
| K193610 | BreathID Smart System | Exalenz Bioscience , Ltd. | 2020-02-06 |
| K173772 | BreathID Hp System | Exalenz Bioscience , Ltd. | 2018-03-08 |
| K173777 | BreathID Hp Lab System | Exalenz Bioscience , Ltd. | 2018-03-08 |
| K162150 | BreathID Hp Lab System | Exalenz Bioscience , Ltd. | 2016-10-31 |
| K130524 | BREATHID HP SYSTEM | Exalenz Bioscience , Ltd. | 2013-05-22 |
| K093834 | CRIT-LINE ANEMIA MANAGEMENT SOFTWARE | Hema Metrics, LLC | 2010-09-29 |
| K092817 | POC-AS10 AUTO SAMPLER | Otsuka Pharmaceutical Co., Ltd. | 2010-03-09 |
| K041148 | POCONE INFRARED SPECTROPHOTOMETER | Otsuka Pharmaceutical Co., Ltd. | 2004-07-15 |
| K014225 | BREATHTEK - UBIT UBT FOR H. PYLORI | Meretek Diagnostics, Inc. | 2002-01-17 |
| K011668 | VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI | Oridion Medical 1987 , Ltd. | 2001-07-09 |
| K000316 | MERETEK UBT_LITE BREATH TEST FOR H. PYLORI | Meretek | 2000-02-24 |
| K990931 | EZ-HBT HELICOBACTER BLOOD TEST | Metabolic Solutions, Inc. | 1999-09-24 |
| K973000 | ALIMENTERICS LARA (TM) BREATH TEST SYSTEM | Alimenterics, Inc. | 1998-02-26 |
| K972352 | THE MERETEK UBT BREATH TEST FOR H.PYLORI | Meretek Diagnostics, Inc. | 1997-10-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07290016923063 | Auto Sampler (for BreathID Hp Lab System) | MERIDIAN BIOSCIENCE ISRAEL LTD | 2024-07-22 |
| 07290016923384 | BreathID Hp Lab Device | MERIDIAN BIOSCIENCE ISRAEL LTD | 2024-07-22 |
| 07290016923391 | BreathID Hp Lab Device (WIN) | MERIDIAN BIOSCIENCE ISRAEL LTD | 2024-07-22 |
| 07290016923148 | BreathID Hp System | MERIDIAN BIOSCIENCE ISRAEL LTD | 2023-04-11 |
| 07290016923162 | BreathID Hp Lab System refurbished | MERIDIAN BIOSCIENCE ISRAEL LTD | 2023-04-11 |
| 07290016923278 | BreathID Smart System refurbished | MERIDIAN BIOSCIENCE ISRAEL LTD | 2023-04-11 |
| 07290016923346 | BreathID Smart System | MERIDIAN BIOSCIENCE ISRAEL LTD | 2023-04-11 |
| 07290016923353 | BreathID Smart System | MERIDIAN BIOSCIENCE ISRAEL LTD | 2023-04-11 |
| 07290016923056 | BreathID Hp System | MERIDIAN BIOSCIENCE ISRAEL LTD | 2021-12-15 |
| 07290016923070 | BreathID Hp Lab System | MERIDIAN BIOSCIENCE ISRAEL LTD | 2021-12-15 |
| 07290016923223 | BreathID Smart System | MERIDIAN BIOSCIENCE ISRAEL LTD | 2021-12-15 |