The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Bioplex 2200 Ebv Igm Panel On Bioplex 2200 Multi-analyte Detection System.
| Device ID | K062213 |
| 510k Number | K062213 |
| Device Name: | BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
| Classification | Epstein-barr Virus, Other |
| Applicant | BIO-RAD LABORATORIES, INC. 6565 185TH AVE., N.E. Redmond, WA 98052 |
| Contact | David Bhend |
| Correspondent | David Bhend BIO-RAD LABORATORIES, INC. 6565 185TH AVE., N.E. Redmond, WA 98052 |
| Product Code | LSE |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-01 |
| Decision Date | 2006-12-08 |
| Summary: | summary |