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 |