LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers
FDA 510(k) clearance K150879 · decided 2015-06-22
Clearance details
- K-number
- K150879
- Device name
- LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers
- Applicant
- DiaSorin, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-04-01
- Decision date
- 2015-06-22
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- CEW
- Device class
- 2
- Regulation number
- 862.1545
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Stillwater, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.