The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Dac-cel Pth Kit Rd51.
| Device ID | K831069 |
| 510k Number | K831069 |
| Device Name: | DAC-CEL PTH KIT RD51 |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | WELLCOME DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-04 |
| Decision Date | 1983-06-16 |