DEN · Class I · 21 CFR 866.5420

FDA Product Code DEN: Alpha-1-t-glycoprotein, Antigen, Antiserum, Control

Leading manufacturers include Hyland Therapeutic Div., Travenol Laboratories and Icl Scientific.

2
Total
2
Cleared
17d
Avg days
1977
Since

FDA 510(k) Cleared Alpha-1-t-glycoprotein, Antigen, Antiserum, Control Devices (Product Code DEN)

2 devices
1–2 of 2
Cleared Mar 17, 1978
RID SYSTEM-HUMAN C-REACTIVE PROTEIN
K780325
Icl Scientific
Immunology · 18d
Cleared Oct 19, 1977
GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID
K771879
Hyland Therapeutic Div., Travenol Laboratories
Immunology · 15d

About Product Code DEN - Regulatory Context