The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Multi-analyte Detection Systems.
| Device ID | K112810 |
| 510k Number | K112810 |
| Device Name: | MULTI-ANALYTE DETECTION SYSTEMS |
| Classification | Antibodies, Anti-cyclic Citrullinated Peptide (ccp) |
| 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 | NHX |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-27 |
| Decision Date | 2011-10-26 |
| Summary: | summary |