LGJ · Class II · 21 CFR 862.3035

FDA Product Code LGJ: Fluorescence Polarization Immunoassay, Amibacin

Leading manufacturers include Roche Diagnostic Systems, Inc. and Roche Diagnostics Corp..

3
Total
3
Cleared
65d
Avg days
1986
Since

FDA 510(k) Cleared Fluorescence Polarization Immunoassay, Amibacin Devices (Product Code LGJ)

3 devices
1–3 of 3
Cleared Jul 22, 1999
COBAS INTEGRA AMIKACIN MAB
K991597
Roche Diagnostics Corp.
Toxicology · 73d
Cleared Jun 13, 1994
COBAS-FP REAGENTS AND CALIBRATORS
K941712
Roche Diagnostic Systems, Inc.
Toxicology · 68d

About Product Code LGJ - Regulatory Context