Heraeus Kulzer, Inc. - FDA 510(k) Cleared Devices
145
Total
145
Cleared
0
Denied
145 devices
Cleared
Aug 02, 1990
GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD
General & Plastic Surgery
63d
Cleared
Mar 29, 1990
GLUCOMETER GX BLOOD GLUCOSE METER
Chemistry
100d
Cleared
Feb 01, 1990
MODIFIED GLUMA BONDING SYSTEM
Dental
87d
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 24, 1989
CLINISTAT HEMOGLOBIN REAGENT TEST
Hematology
66d
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
Cleared
Jan 23, 1989
CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST
Chemistry
168d
Cleared
Jan 13, 1989
CLINISTAT GLUCOSE REAGENT TEST
Chemistry
60d
Cleared
Oct 25, 1988
CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST
Chemistry
81d
Looking for a specific device from Heraeus Kulzer, Inc.? Search by device name or K-number.
Search all Heraeus Kulzer, Inc. devices