Baxter Diagnostics, Inc. - FDA 510(k) Cleared Devices
72
Total
72
Cleared
0
Denied
72 devices
Cleared
Oct 22, 1993
STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY
Chemistry
98d
Cleared
Oct 08, 1993
STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY
Chemistry
73d
Cleared
Sep 24, 1993
PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS
Toxicology
113d
Cleared
Sep 24, 1993
DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2
Chemistry
72d
Cleared
Sep 22, 1993
DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI
Hematology
84d
Cleared
Aug 26, 1993
STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
Chemistry
44d
Cleared
Aug 05, 1993
DADE(R) TUMOR MARKER CONTROL
Immunology
310d
Cleared
Jul 20, 1993
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
Microbiology
81d
Cleared
Apr 08, 1993
BARTELS CYTOMEGALOVIRUS IGM EIA
Microbiology
316d
Cleared
Apr 08, 1993
BARTELS CYTOMEGALOVIRUS IGG EIA
Microbiology
316d
Cleared
Mar 26, 1993
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
Microbiology
85d
Cleared
Mar 12, 1993
MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL
Microbiology
289d
Cleared
Jan 11, 1993
DADE HEPZYME
Hematology
75d
Cleared
Jan 05, 1993
DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III
Chemistry
35d
Cleared
Dec 15, 1992
BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA
Microbiology
216d
Cleared
Dec 15, 1992
BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA
Microbiology
216d
Cleared
Oct 26, 1992
STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED
Chemistry
75d
Cleared
Oct 19, 1992
STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY
Chemistry
168d
Cleared
Sep 28, 1992
BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA
Microbiology
124d
Cleared
Sep 18, 1992
BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA
Microbiology
114d
Cleared
Sep 17, 1992
BARTELS RUBELLA IGM EIA
Microbiology
113d
Cleared
Sep 17, 1992
BARTELS RUBELLA IGG EIA
Microbiology
113d
Cleared
Sep 17, 1992
STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY
Toxicology
73d
Cleared
Sep 02, 1992
BARTELS RUBEOLA IGG EIA
Microbiology
112d
Cleared
Sep 02, 1992
BARTELS EPSTEIN-BARR VIRUS IGM EIA
Microbiology
112d