Heraeus Kulzer, Inc.
Heraeus Kulzer, Inc. holds FDA 510(k) medical device clearances, first cleared 1988, most recent 2009.
Clearances by Heraeus Kulzer, Inc. — page 2
101–145 of 145- K921701 — DURAFILL BOND
- K920949 — SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5
- K920335 — MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD
- K914513 — PALAVIT G
- K915113 — ENCORE
- K914456 — DENTACOLOR(R) CRE-ACTIVE
- K920337 — MILES LIPASE SERA-PAK METHOD
- K920336 — MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD
- K915336 — TWINLOOK
- K915355 — ADS-GEL AND INSULATING-GEL
- K915335 — SILICOATER SYSTEM
- K915095 — ESTISEAL LC
- K914794 — TECHNICON CHEM 1 PLASMA GLUCOSE
- K913698 — ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL
- K913699 — MODERN MATERIALS ORTHODONTIC RESIN
- K913537 — MEMOSIL C.D.
- K911625 — AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM
- K910165 — CUTTERSIL MUCOSA
- K910166 — CUTTERSIL XL
- K910189 — PERFOURM PUTTY SOFT
- K910360 — CUTTERSIL FUNCTION ACTIVATOR
- K910465 — MELIODENT, DENTURE RESIN
- K905396 — HEMASTIX REAGENT STRIPS
- K904081 — GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM
- K896830 — OPTIMATE HEMOGLOBIN A1C
- K902430 — GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD
- K897015 — GLUCOMETER GX BLOOD GLUCOSE METER
- K896382 — MODIFIED GLUMA BONDING SYSTEM
- K896916 — CLINISTAT TOTAL PROTEIN REAGENT TEST
- K895139 — CLINISTAT HDL CHOLESTEROL REAGENT TEST
- K895138 — CLINISTAT LDH REAGENT TEST
- K895047 — CLINISTAT POTASSIUM REAGENT TEST
- K892801 — CLINISTAT TOTAL BILIRUBIN REAGENT TEST
- K893547 — CLINIMATE-TDA BLOOD CHEMISTRY ANALYZER
- K893548 — SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP
- K890873 — GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3
- K884757 — CLINISTAT CHOLESTEROL REAGENT TEST
- K884528 — SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES
- K885227 — CLINISTAT HEMOGLOBIN REAGENT TEST
- K885134 — CLINISTAT TRIGLYCERIDES REAGENT TEST
- K885144 — CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN
- K885156 — CLINISTAT SGOT (AST) REAGENT TEST
- K883327 — CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST
- K884756 — CLINISTAT GLUCOSE REAGENT TEST
- K883321 — CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.