510(k) K032279

Device: ONLINE TDM AMIKA
Applicant: ROCHE DIAGNOSTICS CORP.
510(k) number: K032279
Product code: KLP
Decision: Substantially Equivalent (SESE)
Decision date: 2003-10-10
Date received: 2003-07-24
Regulation: 862.3035
Classification name: Amikacin Serum Assay
Medical specialty: Toxicology
Review panel: Toxicology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: KERWIN KAUFMAN
Address: 9115 Hague Rd. Indianapolis IN US 46250 46250

FDA Registration Numbers#

3006198300
3003795116
9610126
9610529

Source Documents#

510(k) summary PDF

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
07613336133514	ONLINE TDM Amikacin	Roche Diagnostics GmbH	2020-03-05
04015630998623	Amikacin	Roche Diagnostics GmbH	2016-09-20

Other 510(k) Records For Product Code KLP #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K873426	EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645	Em Diagnostic Systems, Inc.	1987-10-29
K790899	BACTEC	Bd Becton Dickinson Vacutainer Systems Preanalytic	1979-05-23
K780949	BIO-MONITOR AMIKACIN	Monitor Science Corp.	1978-08-14

Legacy Summary#

summary

FDA Review#

Decision Summary