FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
MeMed BV
K Number: K210254
·
Decision Sep 1, 2021
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
3
Applicant Total
3
Review Days
215
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Basic Information
- Device Name
- MeMed BV
- K Number
- K210254
- 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
- January 29, 2021
- Decision Date
- September 1, 2021
- 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 |
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