ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit— 510(k) K230863
Substantially EquivalentZeus Scientific
FDA 510(k) clearance K230863 for ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit, Substantially Equivalent on 2023-07-13. Applicant: Zeus Scientific. Device class: 2.
Clearance details
- Applicant
- Zeus Scientific
- 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
- Branchburg, NJ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.