DER · Class II · 21 CFR 866.5580

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

Leading manufacturers include Roche Diagnostics Corp., Kamiya Biomedical Co. and Bayer Corp..

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 May 18, 2000
BAYER ADVIA IMS SYSTEM
K000921
Bayer Corp.
Chemistry · 57d
Cleared Oct 28, 1999
K-ASSAY APO B
K993354
Kamiya Biomedical Co.
Chemistry · 23d
Cleared Oct 25, 1999
K-ASSAY APO AI
K993345
Kamiya Biomedical Co.
Chemistry · 20d
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
Cleared May 21, 1984
VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN
K840830
Ventrex Laboratories, Inc.
Immunology · 87d
Cleared Jan 05, 1981
ALERT A,HDL-APOLIPOROTEIN A, TEST KIT
K802610
Hyland Therapeutic Div., Travenol Laboratories
Immunology · 76d

About Product Code DER - Regulatory Context