FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE MERETEK UBT BREATH TEST FOR H.PYLORI
K Number: K972352
·
Decision Oct 29, 1997
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
16
Applicant Total
3
Review Days
127
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
- THE MERETEK UBT BREATH TEST FOR H.PYLORI
- K Number
- K972352
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meretek Diagnostics, Inc.
- Date Received
- June 24, 1997
- Decision Date
- October 29, 1997
- 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