Product code LGJ— Clinical Toxicology

AMIKACIN KIT (FPIA)

Classification name: Fluorescence Polarization Immunoassay, Amibacin
Device class: Class 2
Regulation: 21 CFR 862.3035
Advisory panel: Clinical Toxicology
Total cleared: 3
First cleared: 1986-08-04
Most recent: 1999-07-22

Market context for product code LGJ

FDA has cleared 3 devices under product code LGJ between 1986 and 1999, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

19991 clearance
19941 clearance
19861 clearance

Top applicants under product code LGJ

Windsor Laboratories, Inc.1 clearance
Roche Diagnostics Corp.1 clearance
Roche Diagnostic Systems, Inc.1 clearance

Recent clearances under product code LGJ

K991597 — COBAS INTEGRA AMIKACIN MABRoche Diagnostics Corp.·1999-07-22
K941712 — COBAS-FP REAGENTS AND CALIBRATORSRoche Diagnostic Systems, Inc.·1994-06-13
K862248 — AMIKACIN KIT (FPIA)Windsor Laboratories, Inc.·1986-08-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.