Borrelia B31 ViraChip IgG Test Kit— 510(k) K163504
Substantially EquivalentViramed Biotech AG
FDA 510(k) clearance K163504 for Borrelia B31 ViraChip IgG Test Kit, Substantially Equivalent on 2017-07-12. Applicant: Viramed Biotech AG. Device class: 2.
Clearance details
- Applicant
- Viramed Biotech AG
- Product code
- Code LSR
- Device class
- Class 2
- Regulation
- 21 CFR 866.3830
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Planegg, DE
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