Panels › Clinical Toxicology › Product code KLP · Class 2

Amikacin Serum Assay

Regulation 862.3035

0510(k)s in 12 months (4 all time)

0recalls in 12 months (0 all time)

0recalls that name a 510(k)

Top companies in KLP

Company	510(k)s	Recalls
Bd Becton Dickinson Vacutainer Systems Preanalytic	1	0
Em Diagnostic Systems, Inc.	1	0
Monitor Science Corp.	1	0
Roche Diagnostics Corp.	1	0

Decided	510(k)	Device and applicant	Code
Oct 10, 2003	K032279	ONLINE TDM AMIKA Roche Diagnostics Corp.	KLP
Oct 29, 1987	K873426	EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645 Em Diagnostic Systems, Inc.	KLP
May 23, 1979	K790899	BACTEC Bd Becton Dickinson Vacutainer Systems Preanalytic	KLP
Aug 14, 1978	K780949	BIO-MONITOR AMIKACIN Monitor Science Corp.	KLP

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