Submission Details
| 510(k) Number | K113847 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
BORRELIA BURGDORFERI IGG BLOT TEST
Apr 2012
Decision
104d
Days
Class 2
Risk
About This 510(k) Submission
K113847 is an FDA 510(k) clearance for the BORRELIA BURGDORFERI IGG BLOT TEST, 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 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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