The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Bioplex(r) 2200 25-oh Vitamin D Kit, Bioplex(r) 2200 25-oh Vitamin D Calibrator Set, And Bioplex(r) 2200 25-oh Vitamin D.
| Device ID | K141114 |
| 510k Number | K141114 |
| Device Name: | BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D |
| Classification | System, Test, Vitamin D |
| Applicant | Bio-Rad Laboratories 5500 E. 2nd Street Benicia, CA 94510 |
| Contact | Juang Wang |
| Correspondent | Juang Wang Bio-Rad Laboratories 5500 E. 2nd Street Benicia, CA 94510 |
| Product Code | MRG |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-30 |
| Decision Date | 2015-01-09 |
| Summary: | summary |