Submission Details
| 510(k) Number | K113846 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 29, 2011 |
| Decision Date | June 01, 2012 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
BORRELIA BURGDORFERI IGM BLOT TEST
Jun 2012
Decision
155d
Days
Class 2
Risk
About This 510(k) Submission
K113846 is an FDA 510(k) clearance for the BORRELIA BURGDORFERI IGM 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 June 1, 2012, 155 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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