DEL · Class I · 21 CFR 866.5590

FDA Product Code DEL: Lipoprotein X, Antigen, Antiserum, Control

Leading manufacturers include Sigma Chemical Co., Roche Diagnostics Corp. and Catachem, Inc..

5
Total
5
Cleared
36d
Avg days
1989
Since

FDA 510(k) Cleared Lipoprotein X, Antigen, Antiserum, Control Devices (Product Code DEL)

5 devices
1–5 of 5
Cleared Nov 15, 2001
TINA-QUANT APOLIPOPROTEIN A-1 VER.2
K013278
Roche Diagnostics Corp.
Chemistry · 45d
Cleared Apr 26, 1990
APOLIPOPROTEIN A-I (APO A-I)
K901675
Sigma Chemical Co.
Immunology · 16d
Cleared Mar 02, 1990
APOLIPOPROTEIN B (APO B)
K900124
Sigma Chemical Co.
Immunology · 52d
Cleared Jun 21, 1989
BACTON TM, BASIC TM, APO A-I REAGENT
K893885
Catachem, Inc.
Chemistry · 22d

About Product Code DEL - Regulatory Context