ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01
FDA 510(k) clearance K072149 · decided 2008-01-15
Clearance details
- K-number
- K072149
- Device name
- ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01
- Applicant
- Phadia US, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-08-03
- Decision date
- 2008-01-15
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- LLL
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Portage, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.