The following data is part of a premarket notification filed by Tudor Laboratories, Inc. with the FDA for Digitoxin (fpia) Kit.
| Device ID | K913240 |
| 510k Number | K913240 |
| Device Name: | DIGITOXIN (FPIA) KIT |
| Classification | Enzyme Immunoassay, Digitoxin |
| Applicant | TUDOR LABORATORIES, INC. 2170 LONE STAR DR. Dallas, TX 75212 |
| Contact | Robert M Dowben |
| Correspondent | Robert M Dowben TUDOR LABORATORIES, INC. 2170 LONE STAR DR. Dallas, TX 75212 |
| Product Code | LFM |
| CFR Regulation Number | 862.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-22 |
| Decision Date | 1991-09-06 |