BreathID Hp Lab System
FDA 510(k) clearance K162150 · decided 2016-10-31
Clearance details
- K-number
- K162150
- Device name
- BreathID Hp Lab System
- Applicant
- Exalenz Bioscience , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-08-02
- Decision date
- 2016-10-31
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MSQ
- Device class
- 1
- Regulation number
- 866.3110
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Modiin, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BreathID Hp System (K221896) | Meridian Bioscience Israel , Ltd. | 2022-12-19 |
| BreathID® Smart System (K223185) | Meridian Bioscience Israel , Ltd. | 2022-11-10 |
| BreathID Hp Lab System, BreathID Smart System (K220494) | Meridian Bioscience Israel , Ltd. | 2022-06-23 |
| BreathID Smart System (K193610) | Exalenz Bioscience , Ltd. | 2020-02-06 |
| BreathID Hp System (K173772) | Exalenz Bioscience , Ltd. | 2018-03-08 |
| BreathID Hp Lab System (K173777) | Exalenz Bioscience , Ltd. | 2018-03-08 |
| BREATHID HP SYSTEM (K130524) | Exalenz Bioscience , Ltd. | 2013-05-22 |
| CRIT-LINE ANEMIA MANAGEMENT SOFTWARE (K093834) | Hema Metrics, LLC | 2010-09-29 |
| POC-AS10 AUTO SAMPLER (K092817) | Otsuka Pharmaceutical Co., Ltd. | 2010-03-09 |
| POCONE INFRARED SPECTROPHOTOMETER (K041148) | Otsuka Pharmaceutical Co., Ltd. | 2004-07-15 |
| BREATHTEK - UBIT UBT FOR H. PYLORI (K014225) | Meretek Diagnostics, Inc. | 2002-01-17 |
| VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI (K011668) | Oridion Medical 1987 , Ltd. | 2001-07-09 |
Recalls involving this device
No recalls on record reference this clearance.