LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
FDA 510(k) clearance K121944 · decided 2013-01-01
Clearance details
- K-number
- K121944
- Device name
- LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
- Applicant
- DiaSorin, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-07-03
- Decision date
- 2013-01-01
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- CIB
- Device class
- 2
- Regulation number
- 862.1085
- 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.