Baxter Diagnostics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: DRIED GRAM-POSITIVE MIC/COMBO PANELS, DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI, DRIED GRAM-NEGATIVE MIC//COMBO PANELS
72
Total
72
Cleared
0
Denied
FDA 510(k) Regulatory Record - Baxter Diagnostics, Inc. Toxicology ✕
6 devices
Cleared
Nov 22, 1994
STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY
Toxicology
462d
Cleared
Apr 26, 1994
PARAMAX ALCOHOL REAGENT
Toxicology
238d
Cleared
Mar 11, 1994
PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS
Toxicology
113d
Cleared
Nov 26, 1993
PARAMAX(R) PHENYTOIN REAGENT
Toxicology
176d
Cleared
Sep 24, 1993
PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS
Toxicology
113d
Cleared
Sep 17, 1992
STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY
Toxicology
73d