EDIA ANTI-CCP— 510(k) K062045
Substantially EquivalentEuro-Diagnostica AB
FDA 510(k) clearance K062045 for EDIA ANTI-CCP, Substantially Equivalent on 2006-12-04. Applicant: Euro-Diagnostica AB. Device class: 2.
Clearance details
- Applicant
- Euro-Diagnostica AB
- Product code
- Code NHX
- Device class
- Class 2
- Regulation
- 21 CFR 866.5775
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malmo, SE
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More clearances from Euro-Diagnostica AB
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