FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
MeMed BV
K Number: K222332
·
Decision Mar 23, 2023
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
3
Applicant Total
3
Review Days
233
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
- MeMed BV
- K Number
- K222332
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3215
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MeMed Diagnostics, Ltd.
- Date Received
- August 2, 2022
- Decision Date
- March 23, 2023
- Product Code
- QPS
- 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 |
|---|---|---|---|
| QPS | Immunoassay For Host Biomarkers Of Infection | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QPS), ordered by most recent decision date.
MeMed BV
FDA 510(k)
FDA Class 2
·Microbiology
LIAISON MeMed BV, LIAISON MeMed BV Control Set
FDA 510(k)
FDA Class 2
·Microbiology
MeMed BV
FDA 510(k)
FDA Class 2
·Microbiology