Submission Details
| 510(k) Number | K200023 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 06, 2020 |
| Decision Date | April 06, 2020 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
Apr 2020
Decision
91d
Days
Class 2
Risk
About This 510(k) Submission
K200023 is an FDA 510(k) clearance for the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Gold Standard Diagnostics (Davis, US). The FDA issued a Cleared decision on April 6, 2020, 91 days after receiving the submission on January 6, 2020. 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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