The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Bioplex 2200 Apls Igm.
| Device ID | K130528 |
| 510k Number | K130528 |
| Device Name: | BIOPLEX 2200 APLS IGM |
| Classification | System, Test, Anticardiolipin Immunological |
| 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 | 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 | 2013-03-01 |
| Decision Date | 2013-10-21 |
| Summary: | summary |