Submission Details
| 510(k) Number | K172722 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 11, 2017 |
| Decision Date | December 10, 2017 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
Cleared
Traditional
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
Dec 2017
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K172722 is an FDA 510(k) clearance for the Anti-Borrelia burgdorferi US EUROLINE-WB (IgM), a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Euroimmun Us, Inc. (Mountain Lakes, US). The FDA issued a Cleared decision on December 10, 2017, 90 days after receiving the submission on September 11, 2017. 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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