The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Bioplex 2200 Celiac Iga And Igg Kits On The Bioplex 2200 System, Bioplex 2200 Celiac Iga And Igg Calibrator Sets, And Bi.
| Device ID | K130053 |
| 510k Number | K130053 |
| Device Name: | BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | BIO-RAD LABORATORIES, INC. 5500 EAST 2ND ST. Benicia, CA 94510 |
| Contact | Juang Wang |
| Correspondent | Juang Wang BIO-RAD LABORATORIES, INC. 5500 EAST 2ND ST. Benicia, CA 94510 |
| Product Code | MVM |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJX |
| Subsequent Product Code | MST |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-15 |
| Decision Date | 2013-09-19 |
| Summary: | summary |