The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Bioplex 2200 25-oh Vitamin D Kit.
| Device ID | K180577 |
| 510k Number | K180577 |
| Device Name: | BioPlex 2200 25-OH Vitamin D Kit |
| Classification | System, Test, Vitamin D |
| 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 | MRG |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-05 |
| Decision Date | 2018-06-22 |
| Summary: | summary |