The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Bioplex 2200 Hsv-1 And Hsv-2 Igg On The Bioplex 2200 Multi-analyte Detection System.
| Device ID | K090409 |
| 510k Number | K090409 |
| Device Name: | BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
| Classification | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| Applicant | Bio-Rad Laboratories 6565 185TH AVE, NE Redmond, WA 98052 |
| Contact | David V Bhend |
| Correspondent | David V Bhend Bio-Rad Laboratories 6565 185TH AVE, NE Redmond, WA 98052 |
| Product Code | MXJ |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-18 |
| Decision Date | 2009-05-08 |
| Summary: | summary |