Product code LGJ

Device name: Fluorescence Polarization Immunoassay, Amibacin
Medical specialty: Clinical Toxicology
Device class: 2
Regulation number: 862.3035
Review panel: TX
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K991597	COBAS INTEGRA AMIKACIN MAB	Roche Diagnostics Corp.	1999-07-22
K941712	COBAS-FP REAGENTS AND CALIBRATORS	Roche Diagnostic Systems, Inc.	1994-06-13
K862248	AMIKACIN KIT (FPIA)	Windsor Laboratories, Inc.	1986-08-04