DGP · Class II · 21 CFR 866.5510

FDA Product Code DGP: Ige, Fitc, Antigen, Antiserum, Control

Leading manufacturers include Intl. Diagnostic Technology, Sclavo, Inc. and Biomerieux Vitek, Inc..

4
Total
4
Cleared
61d
Avg days
1984
Since

FDA 510(k) Cleared Ige, Fitc, Antigen, Antiserum, Control Devices (Product Code DGP)

4 devices
1–4 of 4
Cleared May 20, 1993
VIDAS TOTAL IGE (IGE) ASSAY
K931224
Biomerieux Vitek, Inc.
Immunology · 71d
Cleared Dec 03, 1986
IMMPULSE IGE ASSAY REAGENTS
K863327
Sclavo, Inc.
Immunology · 98d
Cleared Aug 28, 1984
FIAX TOTAL IGE TEST KIT
K842749
Intl. Diagnostic Technology
Immunology · 46d

About Product Code DGP - Regulatory Context