DES · Class II · 21 CFR 866.5550

FDA Product Code DES: Lambda, Fitc, Antigen, Antiserum, Control

Leading manufacturers include Dako Corp. and Gelco Diagnostics, Inc..

2
Total
2
Cleared
79d
Avg days
1983
Since

FDA 510(k) Cleared Lambda, Fitc, Antigen, Antiserum, Control Devices (Product Code DES)

2 devices
1–2 of 2
Cleared Oct 31, 1983
FITC GOAT ANTI-HUMAN LAMBA
K832267
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Jul 19, 1983
FLUORESCEIN CONJUGATED IMMUNOGLOBULIN
K831903
Dako Corp.
Immunology · 35d

About Product Code DES - Regulatory Context