The following data is part of a premarket notification filed by Cambridge Medical Technology with the FDA for Matched Component Set For Digitoxin.
| Device ID | K834080 |
| 510k Number | K834080 |
| Device Name: | MATCHED COMPONENT SET FOR DIGITOXIN |
| Classification | Radioimmunoassay, Digitoxin (125-i) |
| Applicant | CAMBRIDGE MEDICAL TECHNOLOGY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LCW |
| CFR Regulation Number | 862.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-28 |
| Decision Date | 1984-02-04 |