Submission Details
| 510(k) Number | K191398 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 24, 2019 |
| Decision Date | July 29, 2019 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
Cleared
Traditional
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System
Jul 2019
Decision
66d
Days
Class 2
Risk
About This 510(k) Submission
K191398 is an FDA 510(k) clearance for the ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on July 29, 2019, 66 days after receiving the submission on May 24, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.
Device Classification
| Product Code | LSR — Reagent, Borrelia Serological Reagent |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3830 |
Manufacturer
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