LIAISON MeMed BV, LIAISON MeMed BV Control Set
FDA 510(k) clearance K213936 · decided 2022-07-14
Clearance details
- K-number
- K213936
- Device name
- LIAISON MeMed BV, LIAISON MeMed BV Control Set
- Applicant
- DiaSorin, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-16
- Decision date
- 2022-07-14
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- QPS
- Device class
- 2
- Regulation number
- 866.3215
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Stillwater, MN, US
- 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 |
| MeMed BV (K222332) | MeMed Diagnostics, Ltd. | 2023-03-23 |
| MeMed BV (K210254) | MeMed Diagnostics, Ltd. | 2021-09-01 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S008) | DiaSorin, Inc. | 2025-12-19 |
| LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus (P180047/S041) | DiaSorin, Inc. | 2025-12-19 |
| LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier (P180039/S023) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S021) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S007) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S020) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S037) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S021) | DiaSorin, Inc. | 2025-10-10 |