QUANTIA A1-AT— 510(k) K050596
Substantially EquivalentBiokit, S.A.
FDA 510(k) clearance K050596 for QUANTIA A1-AT, Substantially Equivalent on 2005-05-13. Applicant: Biokit, S.A.. Device class: 2.
Clearance details
- Applicant
- Biokit, S.A.
- Product code
- Code DEM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5130
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Barcelona, ES
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More clearances from Biokit, S.A.
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