The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Bioplex 2200 Apls Igg And Iga Kit And Calibrator And Control Sets.
| Device ID | K103834 |
| 510k Number | K103834 |
| Device Name: | BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | Bio-Rad Laboratories BIOPLEX 2200 DIVISION 5500 EAST SECOND ST Benicia, CA 94510 |
| Contact | Juang Wang |
| Correspondent | Juang Wang Bio-Rad Laboratories BIOPLEX 2200 DIVISION 5500 EAST SECOND ST Benicia, CA 94510 |
| Product Code | MID |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJX |
| Subsequent Product Code | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-30 |
| Decision Date | 2012-03-30 |
| Summary: | summary |