Submission Details
| 510(k) Number | K183446 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 12, 2018 |
| Decision Date | March 12, 2019 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
BioPlex 2200 Lyme Total
Mar 2019
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K183446 is an FDA 510(k) clearance for the BioPlex 2200 Lyme Total, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on March 12, 2019, 90 days after receiving the submission on December 12, 2018. 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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