The following data is part of a premarket notification filed by Pharmacia & Upjohn Co. with the FDA for Varelisa Tg (thyroglobulin) Antibodies,.
| Device ID | K003414 |
| 510k Number | K003414 |
| Device Name: | VARELISA TG (THYROGLOBULIN) ANTIBODIES, |
| 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 | 2000-11-02 |
| Decision Date | 2000-11-27 |