DEX · Class I · 21 CFR 866.5420

FDA Product Code DEX: Alpha-1-b-glycoprotein, Antigen, Antiserum, Control

Leading manufacturers include Icl Scientific, Beckman Instruments, Inc. and J.T. Baker Chemical Co..

5
Total
5
Cleared
34d
Avg days
1976
Since

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

5 devices
1–5 of 5
Cleared Dec 30, 1982
ANTI SERA TO HUMAN OROSCOMUCOID
K823765
Kent Laboratories, Inc.
Immunology · 16d
Cleared Sep 26, 1980
LSA 290 ASSAY REAGENTS/NEPHELOMETRIC
K801909
J.T. Baker Chemical Co.
Immunology · 46d
Cleared Aug 16, 1979
HUMAN ALPHA, ACID GLYCOPROTEIN
K791341
Beckman Instruments, Inc.
Immunology · 31d
Cleared Aug 14, 1978
ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU
K781023
Icl Scientific
Immunology · 56d

About Product Code DEX - Regulatory Context