The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Bioplex 2200 Lyme Total.
| Device ID | K183446 |
| 510k Number | K183446 |
| Device Name: | BioPlex 2200 Lyme Total |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | Bio-Rad Laboratories 5500 East Second Street Benicia, CA 94510 |
| Contact | Arlene Carillo |
| Correspondent | Arlene Carillo Bio-Rad Laboratories 5500 East Second Street Benicia, CA 94510 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-12 |
| Decision Date | 2019-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610520506462 | K183446 | 000 |
| 03610520506455 | K183446 | 000 |
| 03610520506431 | K183446 | 000 |
| 03610520506424 | K183446 | 000 |
| 03610520506417 | K183446 | 000 |
| 03610520506400 | K183446 | 000 |