ADVIA Centaur EBV-VCA IgM— 510(k) K233606
Substantially EquivalentBiokit, S.A.
FDA 510(k) clearance K233606 for ADVIA Centaur EBV-VCA IgM, Substantially Equivalent on 2024-08-07. Applicant: Biokit, S.A.. Device class: 1.
Clearance details
- Applicant
- Biokit, S.A.
- Product code
- Code LSE
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lliçà DAmunt, Barcelona, ES
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