The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Bioplex 2200 Rubella & Cmv Igm Kit On The Bioplex 2200 Multi Analyte Detection System.
| Device ID | K092587 |
| 510k Number | K092587 |
| Device Name: | BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | Bio-Rad Laboratories 5500 E. SECOND ST Benicia, CA 94510 |
| Contact | Patricia Klimley |
| Correspondent | Patricia Klimley Bio-Rad Laboratories 5500 E. SECOND ST Benicia, CA 94510 |
| Product Code | LFX |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFZ |
| Subsequent Product Code | LKQ |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-24 |
| Decision Date | 2010-12-03 |
| Summary: | summary |