K113847 is an FDA 510(k) clearance for the BORRELIA BURGDORFERI IGG BLOT TEST. This device is classified as 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 11, 2012, 104 days after receiving the submission on December 29, 2011.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K113847 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2011 |
| Decision Date | April 11, 2012 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LSR - Reagent, Borrelia Serological Reagent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3830 |