The following data is part of a premarket notification filed by Pharmacia & Upjohn Co. with the FDA for Varelisa Tpo Antibodies, Model 12348/12396.
| Device ID | K993585 |
| 510k Number | K993585 |
| Device Name: | VARELISA TPO ANTIBODIES, MODEL 12348/12396 |
| Classification | System, Test, Thyroid Autoantibody |
| 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 | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-22 |
| Decision Date | 2000-01-05 |
| Summary: | summary |