510(k) K011668
- Device
- VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI
- Applicant
- ORIDION MEDICAL 1987 LTD.
- 510(k) number
- K011668
- Product code
- MSQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-07-09
- Date received
- 2001-05-17
- Regulation
- 866.3110
- Classification name
- Test, Urea (breath Or Blood)
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SANDY BROWN
- Address
- 7 Hamarpe St. P.O. Box 45025 Har Hotzvim Industrial Park Jerusalem IL 91450 91450
FDA Registration Numbers#
- 3005772418
Source Documents#
Other 510(k) Records For Product Code MSQ #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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