The following data is part of a premarket notification filed by Tudor Laboratories, Inc. with the FDA for Thyroxine (fpia) Kit.
| Device ID | K921904 |
| 510k Number | K921904 |
| Device Name: | THYROXINE (FPIA) KIT |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Applicant | TUDOR LABORATORIES, INC. 2170 LONE STAR DR. Dallas, TX 75212 |
| Contact | Robert Dowman |
| Correspondent | Robert Dowman TUDOR LABORATORIES, INC. 2170 LONE STAR DR. Dallas, TX 75212 |
| Product Code | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-21 |
| Decision Date | 1992-06-24 |