Hemagen Diagnostics, Inc. - FDA 510(k) Cleared Devices
52
Total
52
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hemagen Diagnostics, Inc. Chemistry ✕
15 devices
Cleared
Jun 30, 2004
RAICHEM BUN RATE REAGENT (LIQUID)
Chemistry
72d
Cleared
Jun 30, 2004
RAICHEM GLUCOSE UV (LIQUID)
Chemistry
72d
Cleared
Jun 25, 2004
RAICHEM CALCIUM (OCPC) LIQUID REAGENT
Chemistry
67d
Cleared
Jun 16, 2003
RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2
Chemistry
70d
Cleared
Dec 24, 2002
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS...
Chemistry
42d
Cleared
Sep 17, 2002
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
Chemistry
27d
Cleared
Sep 03, 2002
RAICHEM LIPID CALIBRATOR
Chemistry
13d
Cleared
Jul 29, 2002
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
Chemistry
105d
Cleared
Jul 19, 2002
MODIFICATION TO RAICHEM CALCIUM REAGENT
Chemistry
25d
Cleared
Oct 15, 2001
RAICHEM BUN RATE REAGENT
Chemistry
63d
Cleared
Oct 15, 2001
RAICHEM GLUCOSE UV REAGENT
Chemistry
63d
Cleared
Sep 24, 2001
RAICHEM MULTI-ANALYTE CALIBRATOR
Chemistry
69d