FDA 510(k) Applications Submitted by MARY ANN 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. |
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