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.
K941443 03/24/1994 SYNERGY QUAD REMEL CO.
K941444 03/24/1994 BHI AGAR WITH VANCOMYCIN REMEL CO.
K092423 08/07/2009 XPECT FLU A & B Thermo Fisher Scientific
K964421 10/01/1996 REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK REMEL, L.P.
K935124 10/28/1993 BACTICARD CANDIDA REMEL CO.
K936021 12/17/1993 BACTICARD STREP REMEL CO.
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.
K933514 07/20/1993 BACTICARD STREP REMEL CO.
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
K934986 10/19/1993 BACTICARD E. COLI REMEL CO.
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.


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