The following data is part of a premarket notification filed by Pharmacia & Upjohn Co. with the FDA for Varelisa Recombi Ana Profile.
| Device ID | K993109 |
| 510k Number | K993109 |
| Device Name: | VARELISA RECOMBI ANA PROFILE |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | PHARMACIA & UPJOHN CO. 5094 ST. ANDREWS DR. Westervillle, OH 43082 |
| Contact | Karen E Matis |
| Correspondent | Karen E Matis PHARMACIA & UPJOHN CO. 5094 ST. ANDREWS DR. Westervillle, OH 43082 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-17 |
| Decision Date | 1999-11-12 |
| Summary: | summary |