The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Bioplex Vasculitis Kit.
| Device ID | K072358 |
| 510k Number | K072358 |
| Device Name: | BIOPLEX VASCULITIS KIT |
| Classification | Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm) |
| Applicant | Bio-Rad Laboratories 6565 185TH AVE, NE Redmond, WA 98052 |
| Contact | Priya Bondre |
| Correspondent | Priya Bondre Bio-Rad Laboratories 6565 185TH AVE, NE Redmond, WA 98052 |
| Product Code | MVJ |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| Subsequent Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-22 |
| Decision Date | 2007-10-31 |
| Summary: | summary |