K130053 is an FDA 510(k) clearance for the BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI. This device is classified as a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II - Special Controls, product code MVM).
Submitted by Bio-Rad Laboratories, Inc. (Benicia, US). The FDA issued a Cleared decision on September 19, 2013, 247 days after receiving the submission on January 15, 2013.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K130053 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 15, 2013 |
| Decision Date | September 19, 2013 |
| Days to Decision | 247 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | MVM — Autoantibodies, Endomysial(tissue Transglutaminase) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |