MLE · Class II · 21 CFR 866.5110

FDA Product Code MLE: Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control

Leading manufacturers include Inova Diagnostics, Inc., Elias U.S.A., Inc. and Cogent Diagnotics , Ltd..

3
Total
3
Cleared
48d
Avg days
1995
Since

FDA 510(k) Cleared Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control Devices (Product Code MLE)

3 devices
1–3 of 3
Cleared Apr 03, 2001
QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA
K010558
Inova Diagnostics, Inc.
Immunology · 36d
Cleared Aug 24, 1999
AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA
K991942
Cogent Diagnotics , Ltd.
Immunology · 76d
Cleared Apr 17, 1995
VARELISA PARIETAL CELL ANTIBODIES
K951206
Elias U.S.A., Inc.
Immunology · 31d

About Product Code MLE - Regulatory Context