FDA 510(k) Applications Submitted by Sarah Baumann

FDA 510(k) Number	Submission Date	Device Name	Applicant
K100594	03/02/2010	ELECSYS TROPONIN I CALCHECK 5	Roche Diagnostics
K101075	04/19/2010	ELECSYS INSULIN CALCHECK 5	ROCHE DIAGNOSTICS CORP.
K111188	04/27/2011	COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B	Roche Diagnostics
K111506	06/01/2011	ELECSYS PRECICONTROL VARIA 3	Roche Diagnostics
K091601	06/03/2009	ELECYS ANTI-CCP CALCHECK	ROCHE DIAGNOSTICS CORP.
K092168	07/21/2009	ELECSYS HCG+B CALCHECK 5	Roche Diagnostics
K102157	07/30/2010	ELECSYS PRECICONTROL MULTIMARKER	Roche Diagnostics
K092320	08/04/2009	ELECSYS PRECICONTROL THYROAB	Roche Diagnostics
K142133	08/04/2014	ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM	Roche Diagnostics
K102267	08/09/2010	ELECSYS FERRITIN CALCHECK 5	Roche Diagnostics
K102269	08/09/2010	ELECSYS IGE CALCHECK 5	Roche Diagnostics
K092848	09/16/2009	ELECSYS TROPONIN T CALCHECK 5	ROCHE DIAGNOSTICS CORP.
K103171	10/27/2010	ELECSYS ANTI-TPO CALSET	Roche Diagnostics
K093421	11/03/2009	ELECSYS TESTOSTERONE II IMMUNOASSAY	ROCHE DIAGNOSTICS CORP.