510(k) K991597

Device: COBAS INTEGRA AMIKACIN MAB
Applicant: ROCHE DIAGNOSTICS CORP.
510(k) number: K991597
Product code: LGJ
Decision: Substantially Equivalent (SESE)
Decision date: 1999-07-22
Date received: 1999-05-10
Regulation: 862.3035
Classification name: Fluorescence Polarization Immunoassay, Amibacin
Medical specialty: Toxicology
Review panel: Toxicology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: LISA GERARD
Address: 9115 Hague Rd., P.O. Box 50457 Indianapolis IN US 46250 46250

FDA Registration Numbers#

9610126

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
04015630915576	Amikacin	Roche Diagnostics GmbH	2016-09-20

Other 510(k) Records For Product Code LGJ #

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

Legacy Summary#

summary

FDA Review#

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