DER · Class II · 21 CFR 866.5580

FDA Product Code DER: Alpha-1-lipoprotein, Antigen, Antiserum, Control

Leading manufacturers include Roche Diagnostics Corp., Roche Diagnostic Systems, Inc. and Abbott Laboratories.

17
Total
17
Cleared
93d
Avg days
1981
Since

FDA 510(k) Cleared Alpha-1-lipoprotein, Antigen, Antiserum, Control Devices (Product Code DER)

17 devices
1–17 of 17
Cleared Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN VER.2
K013249
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Apr 14, 1999
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
K990594
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Jan 29, 1999
APOLIPOPROTEIN A1
K983289
Abbott Laboratories
Immunology · 133d
Cleared May 08, 1991
ROCHE APOLIPOPROTEIN STANDARD
K910553
Roche Diagnostic Systems, Inc.
Immunology · 90d

About Product Code DER - Regulatory Context