DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS
FDA 510(k) clearance K073390 · decided 2008-11-21
Clearance details
- K-number
- K073390
- Device name
- DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS
- Applicant
- DiaSorin, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-12-03
- Decision date
- 2008-11-21
- Days to decision
- 354 days
- Clearance type
- Traditional
- Product code
- LFX
- Device class
- 2
- Regulation number
- 866.3510
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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.