Atlas FDA

ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit

FDA 510(k) clearance K230863 · decided 2023-07-13

Clearance details

K-number
K230863
Device name
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
Applicant
Zeus Scientific
Decision
Substantially Equivalent
Date received
2023-03-29
Decision date
2023-07-13
Days to decision
106 days
Clearance type
Traditional
Product code
LSR
Device class
2
Regulation number
866.3830
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Branchburg, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.