DAC-CEL HCG-MCA KIT RD52

Radioimmunoassay, Human Growth Hormone

WELLCOME DIAGNOSTICS

The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Dac-cel Hcg-mca Kit Rd52.

Pre-market Notification Details

Device IDK831073
510k NumberK831073
Device Name:DAC-CEL HCG-MCA KIT RD52
ClassificationRadioimmunoassay, Human Growth Hormone
Applicant WELLCOME DIAGNOSTICS 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCFL  
CFR Regulation Number862.1370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-04-04
Decision Date1983-09-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.