FDA 510(k) Applications Submitted by KERRIE S OETTER

FDA 510(k) Number	Submission Date	Device Name	Applicant
K040025	01/07/2004	A1C-CELLULAR	STRECK LABORATORIES, INC.
K060083	01/11/2006	NRBC-CHEX FOR LH	Streck
K040107	01/20/2004	CYTO-CHEX BCT	STRECK LABORATORIES, INC.
K090137	01/21/2009	STAK-CHEX PLUS RETICS	Streck
K070199	01/22/2007	RETIC-CHEX LINEARITY FOR BC	Streck
K090201	01/27/2009	UA-CELLULAR FOR IQ	Streck
K121214	04/23/2012	ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM	BECKMAN COULTER, INC.
K101335	05/12/2010	CELL-CHEX	Streck
K121790	06/18/2012	ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM	BECKMAN COULTER, INC.
K042587	09/22/2004	RETIC-CHEX FOR CELL-DYN	STRECK LABORATORIES, INC.
K063218	10/24/2006	E-CHECK (XE)	Streck
K223403	11/09/2022	LIAISON Anti-HAV; LIAISON XS	DiaSorin Inc.
K053362	12/02/2005	CELL-CHEX AUTO	Streck
K083926	12/31/2008	CD4 COUNT	Streck
K111952	07/11/2011	ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033	BECKMAN COULTER, INC.
K172783	09/15/2017	Access hs Tnl	Beckman Coulter, Inc.