FDA 510(k) Applications Submitted by MARY A SILVIUS

FDA 510(k) Number	Submission Date	Device Name	Applicant
K970830	03/07/1997	REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK	REMEL, INC.
K970831	03/07/1997	REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK	REMEL, INC.
K970832	03/07/1997	PYR SWAB	REMEL, INC.
K970833	03/07/1997	INDOLE SWAB	REMEL, INC.
K970834	03/07/1997	GRAM SWAB	REMEL, INC.
K092423	08/07/2009	XPECT FLU A & B	Thermo Fisher Scientific
K964421	10/01/1996	REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK	REMEL, L.P.
K960090	01/11/1996	CALCOFLUOR WHITE STAIN KIT	REMEL CO.
K960313	01/22/1996	MUELLER HINTON AGAR WITH 2% NACI	REMEL, L.P.
K961046	03/15/1996	10B ARGININE BROTH	REMEL, L.P.
K981391	04/17/1998	PAR-ONE	REMEL, INC.
K961818	05/10/1996	GENTAMICIN DISK (120MCG)	REMEL, L.P.
K961819	05/10/1996	STREPTOMYCIN DISK (300MCG)	REMEL, L.P.
K031565	05/19/2003	XPECT INFLUENZA A/B	REMEL INC
K972359	06/25/1997	REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN	REMEL, L.P.
K041951	07/20/2004	XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B	REMEL INC
K092407	08/06/2009	REMEL SPECTRA MRSA	REMEL, INC.
K092819	09/14/2009	REMEL SPECTRA VRE	Thermo Fisher Scientific
K073027	10/26/2007	SPECTRA MRSA	Thermo Fisher Scientific
K954986	10/31/1995	GC BASE W/ 1% GCHI	REMEL, L.P.
K955669	12/13/1995	REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK	REMEL CO.
K965149	12/23/1996	A.C.T. I	REMEL CO.
K965150	12/23/1996	A.C.T. IV	REMEL CO.
K965151	12/23/1996	A.C.T. III	REMEL CO.
K965152	12/23/1996	A.C.T. II	REMEL CO.