The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Dac-cel Hcg-mca Kit Rd52.
| Device ID | K831073 |
| 510k Number | K831073 |
| Device Name: | DAC-CEL HCG-MCA KIT RD52 |
| Classification | Radioimmunoassay, Human Growth Hormone |
| Applicant | WELLCOME DIAGNOSTICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CFL |
| CFR Regulation Number | 862.1370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-04 |
| Decision Date | 1983-09-01 |