MeMed BV
FDA 510(k) clearance K222332 · decided 2023-03-23
Clearance details
- K-number
- K222332
- Device name
- MeMed BV
- Applicant
- MeMed Diagnostics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-08-02
- Decision date
- 2023-03-23
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- QPS
- Device class
- 2
- Regulation number
- 866.3215
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Tirat Carmel, 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 |
|---|---|---|
| MeMed BV (K230944) | MeMed Diagnostics, Ltd. | 2023-06-30 |
| LIAISON MeMed BV, LIAISON MeMed BV Control Set (K213936) | DiaSorin, Inc. | 2022-07-14 |
| MeMed BV (K210254) | MeMed Diagnostics, Ltd. | 2021-09-01 |
Recalls involving this device
No recalls on record reference this clearance.