510(k) K894531

Device: FPR TOBRAMYCIN KIT
Applicant: COLONY LABORATORIES, INC.
510(k) number: K894531
Product code: LFW
Decision: Substantially Equivalent (SESE)
Decision date: 1989-09-01
Date received: 1989-07-20
Regulation: 862.3900
Classification name: Fluorescence Polarization Immunoassay, Tobramycin
Medical specialty: Toxicology
Review panel: Toxicology
Device class: 2
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Contact: DALE B HINSON
Address: 1220 Nineteenth St., NW Fourth Floor Washington DC US 20036 20036

FDA Registration Numbers#

3010939897
9610126

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LFW #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K964670	ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN	Roche Diagnostic Systems, Inc.	1997-02-04
K944371	TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR	Sigma Diagnostics, Inc.	1994-11-10
K941614	AXSYM TOBRAMYCIN	Abbott Laboratories	1994-08-18
K912143	CEDIA(R) TOBRAMYCIN ASSAY	Microgenics Corp.	1991-07-26
K900707	MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR	Innotron of Oregon, Inc.	1990-04-20
K872562	INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET	Innotron of Oregon, Inc.	1987-08-17
K854392	TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU	Windsor Laboratories, Inc.	1985-12-05
K843828	COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA	Roche Diagnostic Systems, Inc.	1985-02-01
K841866	INNOFLOUR TOBRAMYCIN	Innotron Diagnostics	1984-05-31

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases