Baxter Healthcare Corp - FDA 510(k) Cleared Devices
505
Total
496
Cleared
0
Denied
FDA 510(k) cleared devices by Baxter Healthcare Corp Microbiology ✕
18 devices
Cleared
Oct 12, 1993
SYNERGY SCREEN TEST, MODIFICATION
Microbiology
539d
Cleared
Dec 29, 1992
BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY
Microbiology
141d
Cleared
Dec 11, 1992
DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS
Microbiology
199d
Cleared
Nov 19, 1991
WALKAWAY TM 40
Microbiology
235d
Cleared
Mar 12, 1991
CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY
Microbiology
173d
Cleared
Oct 16, 1990
BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN
Microbiology
41d
Cleared
Jul 31, 1990
BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2
Microbiology
43d
Cleared
Jul 31, 1990
BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST
Microbiology
43d
Cleared
Jun 15, 1990
BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT
Microbiology
130d
Cleared
Feb 02, 1990
VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY
Microbiology
72d
Cleared
Sep 05, 1989
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS
Microbiology
83d
Cleared
Aug 15, 1989
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS
Microbiology
74d
Cleared
Aug 10, 1989
CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY
Microbiology
66d
Cleared
Sep 07, 1988
GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS
Microbiology
56d
Cleared
Sep 07, 1988
GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS
Microbiology
27d
Cleared
Aug 15, 1988
FASTIDIOUS INOCULUM BROTH
Microbiology
33d
Cleared
Apr 12, 1988
GRAM NEGATIVE MIC/COMBO PANELS
Microbiology
71d
Cleared
Jan 11, 1988
GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL
Microbiology
42d