The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Dac-cel Diagnatal Rd 50.
| Device ID | K830203 |
| 510k Number | K830203 |
| Device Name: | DAC-CEL DIAGNATAL RD 50 |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | WELLCOME DIAGNOSTICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-20 |
| Decision Date | 1983-02-18 |