The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Bioplex 2200 Syphilis Igg Kit On The Bioplex 2200 Multi-analyte Detection System.
| Device ID | K063866 |
| 510k Number | K063866 |
| Device Name: | BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | Bio-Rad Laboratories 6565 185TH AVE, NE Redmond, WA 98052 |
| Contact | David Bhend |
| Correspondent | David Bhend Bio-Rad Laboratories 6565 185TH AVE, NE Redmond, WA 98052 |
| Product Code | LIP |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-29 |
| Decision Date | 2007-03-19 |
| Summary: | summary |