ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01— 510(k) K072149
Substantially EquivalentPhadia US, Inc.
FDA 510(k) clearance K072149 for ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01, Substantially Equivalent on 2008-01-15. Applicant: Phadia US, Inc.. Device class: 2.
Clearance details
- Applicant
- Phadia US, Inc.
- Product code
- Product code LLL
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portage, MI, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.