LKP · Class II · 21 CFR 866.5100

FDA Product Code LKP: Anti-sm Antibody, Antigen And Control

Leading manufacturers include Shield Diagnostics, Ltd., General Biometrics, Inc. and Bio-Rad.

28
Total
28
Cleared
99d
Avg days
1984
Since
28 devices
25–28 of 28
Cleared May 16, 1988
WESBLOT RNP-SM TEST
K881379
American Bionetics, Inc.
Immunology · 45d
Cleared Apr 06, 1988
SM ANTIBODY TEST KIT
K880254
Lipogen, Inc.
Immunology · 77d
Cleared Nov 04, 1987
IMMUSTRIP(TM) SM ELISA TEST SYSTEM
K873741
Immunomedics, Inc.
Immunology · 49d
Cleared Jun 25, 1984
ENZYMATIC ACETAMINOPHEN ASSAY
K841930
Diagnostic Chemicals, Ltd. (Usa)
Toxicology · 46d