The following data is part of a premarket notification filed by Bio-rad with the FDA for Platelia Lyme Igg Assay.
| Device ID | K080012 |
| 510k Number | K080012 |
| Device Name: | PLATELIA LYME IGG ASSAY |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | BIO-RAD 163 CABOT ST. Beverly, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White BIO-RAD 163 CABOT ST. Beverly, MA 01915 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-03 |
| Decision Date | 2008-05-08 |
| Summary: | summary |