Heraeus Kulzer, Inc. - FDA 510(k) Cleared Devices
145
Total
145
Cleared
0
Denied
53 devices
Cleared
Sep 09, 1992
MILES URINE UREA NITROGEN METHOD
Chemistry
82d
Cleared
Sep 09, 1992
URINE CHLORIDE
Chemistry
82d
Cleared
Aug 24, 1992
MILES POTASSIUM METHOD
Chemistry
66d
Cleared
Aug 24, 1992
MILES URINE CREATININE METHOD
Chemistry
66d
Cleared
Mar 24, 1992
MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD
Chemistry
60d
Cleared
Mar 18, 1992
ENCORE
Chemistry
126d
Cleared
Mar 11, 1992
MILES LIPASE SERA-PAK METHOD
Chemistry
47d
Cleared
Mar 04, 1992
MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD
Chemistry
40d
Cleared
Dec 18, 1991
TECHNICON CHEM 1 PLASMA GLUCOSE
Chemistry
56d
Cleared
Feb 11, 1991
HEMASTIX REAGENT STRIPS
Chemistry
73d
Cleared
Dec 26, 1990
GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM
Chemistry
112d
Cleared
Mar 29, 1990
GLUCOMETER GX BLOOD GLUCOSE METER
Chemistry
100d
Cleared
Jan 19, 1990
CLINISTAT TOTAL PROTEIN REAGENT TEST
Chemistry
39d
Cleared
Dec 27, 1989
CLINISTAT HDL CHOLESTEROL REAGENT TEST
Chemistry
133d
Cleared
Oct 19, 1989
CLINISTAT LDH REAGENT TEST
Chemistry
64d
Cleared
Oct 17, 1989
CLINISTAT POTASSIUM REAGENT TEST
Chemistry
69d
Cleared
Aug 15, 1989
CLINISTAT TOTAL BILIRUBIN REAGENT TEST
Chemistry
120d
Cleared
Aug 03, 1989
CLINIMATE-TDA BLOOD CHEMISTRY ANALYZER
Chemistry
87d
Cleared
Aug 03, 1989
SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP
Chemistry
87d
Cleared
Apr 04, 1989
GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3
Chemistry
42d
Cleared
Mar 10, 1989
CLINISTAT CHOLESTEROL REAGENT TEST
Chemistry
116d
Cleared
Mar 08, 1989
SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES
Chemistry
131d
Cleared
Feb 10, 1989
CLINISTAT TRIGLYCERIDES REAGENT TEST
Chemistry
60d
Cleared
Feb 02, 1989
CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN
Chemistry
49d
Cleared
Feb 02, 1989
CLINISTAT SGOT (AST) REAGENT TEST
Chemistry
49d