FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇱 Israel
BreathID Hp Lab System
K Number: K162150
·
Decision Oct 31, 2016
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
16
Applicant Total
5
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BreathID Hp Lab System
- K Number
- K162150
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Exalenz Bioscience , Ltd.
- Date Received
- August 2, 2016
- Decision Date
- October 31, 2016
- Product Code
- MSQ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MSQ | Test, Urea (Breath Or Blood) | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MSQ), ordered by most recent decision date.
BreathID Hp System
FDA 510(k)
FDA Class 1
·Microbiology
BreathID® Smart System
FDA 510(k)
FDA Class 1
·Microbiology
BreathID Hp Lab System, BreathID Smart System
FDA 510(k)
FDA Class 1
·Microbiology
BreathID Smart System
FDA 510(k)
FDA Class 1
·Microbiology
BreathID Hp Lab System
FDA 510(k)
FDA Class 1
·Microbiology
BreathID Hp System
FDA 510(k)
FDA Class 1
·Microbiology