The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Varelisa Recombi Ana Screen, Model 12 596.
| Device ID | K083188 |
| 510k Number | K083188 |
| Device Name: | VARELISA RECOMBI ANA SCREEN, MODEL 12 596 |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Contact | Martin R Mann |
| Correspondent | Martin R Mann PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-29 |
| Decision Date | 2009-03-13 |
| Summary: | summary |