The following data is part of a premarket notification filed by Pharmacia & Upjohn Co. with the FDA for Varelisa Sm Antibodies.
| Device ID | K000312 |
| 510k Number | K000312 |
| Device Name: | VARELISA SM ANTIBODIES |
| Classification | Anti-sm Antibody, Antigen And Control |
| Applicant | PHARMACIA & UPJOHN CO. 5094 ST. ANDREWS DR. Westervillle, OH 43082 |
| Contact | Karen Matis |
| Correspondent | Karen Matis PHARMACIA & UPJOHN CO. 5094 ST. ANDREWS DR. Westervillle, OH 43082 |
| Product Code | LKP |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-01 |
| Decision Date | 2000-03-17 |