The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Bioplex 2200 Anti-ccp Kit On The Bioplex 2200 Multi-analyte Detection System.
| Device ID | K093954 |
| 510k Number | K093954 |
| Device Name: | BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
| 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 |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-23 |
| Decision Date | 2010-08-24 |
| Summary: | summary |