VARELISA RECOMBI ANA SCREEN, MODEL 12 596— 510(k) K083188
Substantially EquivalentPhadia US, Inc.
FDA 510(k) clearance K083188 for VARELISA RECOMBI ANA SCREEN, MODEL 12 596, Substantially Equivalent on 2009-03-13. Applicant: Phadia US, Inc.. Device class: 2.
Clearance details
- Applicant
- Phadia US, Inc.
- Product code
- Code LJM
- 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.