FDA 510(k) Applications Submitted by CHARLES C ALLAIN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K980012 |
01/02/1998 |
CREATINE KINASE REAGENT |
AC BIOCHEMICALS, INC. |
| K980013 |
01/02/1998 |
AMYLASE |
AC BIOCHEMICALS, INC. |
| K970867 |
03/10/1997 |
URIC ACID REAGENT |
DERMA MEDIA LAB., INC. |
| K971005 |
03/19/1997 |
TRIGLYCERIDES |
DERMA MEDIA LAB., INC. |
| K971072 |
03/24/1997 |
CHOLESTEROL REAGENT |
DERMA MEDIA LAB., INC. |
| K971309 |
04/08/1997 |
UREA |
DERMA MEDIA LAB., INC. |
| K955781 |
12/21/1995 |
ALBUMIN |
DERMA MEDIA LAB., INC. |
| K955936 |
12/21/1995 |
TOTAL PROTEIN REAGENT |
DERMA MEDIA LAB., INC. |
| K955937 |
12/21/1995 |
INORGANIC PHOSPHORUS REAGENT |
DERMA MEDIA LAB., INC. |
| K955938 |
12/21/1995 |
CREATININE REAGENT |
DERMA MEDIA LAB., INC. |
| K955939 |
12/21/1995 |
CALCIUM REAGENT |
DERMA MEDIA LAB., INC. |
| K955940 |
12/21/1995 |
TOTAL BILIRUBIN REAGENT |
DERMA MEDIA LAB., INC. |
| K970664 |
02/21/1997 |
GLUCOSE REAGENT |
DERMA MEDIA LAB., INC. |
| K964912 |
12/09/1996 |
LACTATE DEHYDROGENASE |
DERMA MEDIA LAB., INC. |
| K964913 |
12/09/1996 |
IRON REAGENT |
DERMA MEDIA LAB., INC. |
| K964914 |
12/09/1996 |
ALKALINE PHOSPHATASE |
DERMA MEDIA LAB., INC. |
| K964915 |
12/09/1996 |
MAGNESIUM |
DERMA MEDIA LAB., INC. |
| K964916 |
12/09/1996 |
GAMMA-GLUTAMYL TRANSPEPTIDASE |
DERMA MEDIA LAB., INC. |
| K965126 |
12/23/1996 |
AST/SGOT |
DERMA MEDIA LAB., INC. |
| K965134 |
12/23/1996 |
ALT/SGPT |
DERMA MEDIA LAB., INC. |
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