FDA 510(k) Applications Submitted by JOSE A MONTANEZ
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K031101 |
04/07/2003 |
RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 |
HEMAGEN DIAGNOSTICS, INC. |
| K010864 |
03/22/2001 |
ANALYST PANELS + ANALYTICAL TEST ROTOR |
HEMAGEN DIAGNOSTICS, INC. |
| K011126 |
04/13/2001 |
RAICHEM CREATININE URINE STANDARD |
HEMAGEN DIAGNOSTICS, INC. |
| K021194 |
04/15/2002 |
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM |
HEMAGEN DIAGNOSTICS, INC. |
| K022049 |
06/24/2002 |
MODIFICATION TO RAICHEM CALCIUM REAGENT |
HEMAGEN DIAGNOSTICS, INC. |
| K012250 |
07/17/2001 |
RAICHEM MULTI-ANALYTE CALIBRATOR |
HEMAGEN DIAGNOSTICS, INC. |
| K012649 |
08/13/2001 |
RAICHEM BUN RATE REAGENT |
HEMAGEN DIAGNOSTICS, INC. |
| K012668 |
08/13/2001 |
RAICHEM GLUCOSE UV REAGENT |
HEMAGEN DIAGNOSTICS, INC. |
| K022767 |
08/21/2002 |
RAICHEM LIPID CALIBRATOR |
HEMAGEN DIAGNOSTICS, INC. |
| K022772 |
08/21/2002 |
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT |
HEMAGEN DIAGNOSTICS, INC. |
| K003012 |
09/26/2000 |
RAICHEM PHOSPORUS REAGENT |
HEMAGEN DIAGNOSTICS, INC. |
| K023784 |
11/12/2002 |
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER |
HEMAGEN DIAGNOSTICS, INC. |
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