MOI · Class II · 21 CFR 866.6010

FDA Product Code MOI: System, Test, Immunological, Antigen, Tumor

Leading manufacturers include Beckman Coulter, Inc., Chiron Diagnostics Corp. and Roche Diagnostics Corp..

28
Total
28
Cleared
165d
Avg days
1997
Since
28 devices
25–28 of 28
Cleared Sep 15, 1997
AXSYM CA 15-3
K963926
Abbott Laboratories
Immunology · 350d
Cleared Aug 08, 1997
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
K970695
Chiron Diagnostics Corp.
Immunology · 164d
Cleared Jul 17, 1997
CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER
K971418
Chiron Diagnostics Corp.
Chemistry · 92d
Cleared May 23, 1997
CENTOCOR CA 15-3 RIA MODEL NO. 800-033
K963803
Centocor, Inc.
Immunology · 242d