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Heraeus Kulzer, Inc.

145 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
DURAFILL BOND (K921701)Heraeus Kulzer, Inc.1992-06-09
SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5 (K920949)Heraeus Kulzer, Inc.1992-05-15
MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD (K920335)Heraeus Kulzer, Inc.1992-03-24
PALAVIT G (K914513)Heraeus Kulzer, Inc.1992-03-19
ENCORE (K915113)Heraeus Kulzer, Inc.1992-03-18
DENTACOLOR(R) CRE-ACTIVE (K914456)Heraeus Kulzer, Inc.1992-03-11
MILES LIPASE SERA-PAK METHOD (K920337)Heraeus Kulzer, Inc.1992-03-11
MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD (K920336)Heraeus Kulzer, Inc.1992-03-04
TWINLOOK (K915336)Heraeus Kulzer, Inc.1992-02-03
ADS-GEL AND INSULATING-GEL (K915355)Heraeus Kulzer, Inc.1992-01-31
SILICOATER SYSTEM (K915335)Heraeus Kulzer, Inc.1992-01-21
ESTISEAL LC (K915095)Heraeus Kulzer, Inc.1992-01-17
TECHNICON CHEM 1 PLASMA GLUCOSE (K914794)Heraeus Kulzer, Inc.1991-12-18
MODERN MATERIALS ORTHODONTIC RESIN (K913699)Heraeus Kulzer, Inc.1991-10-09
ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL (K913698)Heraeus Kulzer, Inc.1991-10-09
MEMOSIL C.D. (K913537)Heraeus Kulzer, Inc.1991-10-04
AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM (K911625)Heraeus Kulzer, Inc.1991-09-05
PERFOURM PUTTY SOFT (K910189)Heraeus Kulzer, Inc.1991-06-06
CUTTERSIL MUCOSA (K910165)Heraeus Kulzer, Inc.1991-06-06
CUTTERSIL XL (K910166)Heraeus Kulzer, Inc.1991-06-06
MELIODENT, DENTURE RESIN (K910465)Heraeus Kulzer, Inc.1991-06-06
CUTTERSIL FUNCTION ACTIVATOR (K910360)Heraeus Kulzer, Inc.1991-06-06
HEMASTIX REAGENT STRIPS (K905396)Heraeus Kulzer, Inc.1991-02-11
GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM (K904081)Heraeus Kulzer, Inc.1990-12-26
OPTIMATE HEMOGLOBIN A1C (K896830)Heraeus Kulzer, Inc.1990-09-11
GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD (K902430)Heraeus Kulzer, Inc.1990-08-02
GLUCOMETER GX BLOOD GLUCOSE METER (K897015)Heraeus Kulzer, Inc.1990-03-29
MODIFIED GLUMA BONDING SYSTEM (K896382)Heraeus Kulzer, Inc.1990-02-01
CLINISTAT TOTAL PROTEIN REAGENT TEST (K896916)Heraeus Kulzer, Inc.1990-01-19
CLINISTAT HDL CHOLESTEROL REAGENT TEST (K895139)Heraeus Kulzer, Inc.1989-12-27
CLINISTAT LDH REAGENT TEST (K895138)Heraeus Kulzer, Inc.1989-10-19
CLINISTAT POTASSIUM REAGENT TEST (K895047)Heraeus Kulzer, Inc.1989-10-17
CLINISTAT TOTAL BILIRUBIN REAGENT TEST (K892801)Heraeus Kulzer, Inc.1989-08-15
SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP (K893548)Heraeus Kulzer, Inc.1989-08-03
CLINIMATE-TDA BLOOD CHEMISTRY ANALYZER (K893547)Heraeus Kulzer, Inc.1989-08-03
GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3 (K890873)Heraeus Kulzer, Inc.1989-04-04
CLINISTAT CHOLESTEROL REAGENT TEST (K884757)Heraeus Kulzer, Inc.1989-03-10
SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES (K884528)Heraeus Kulzer, Inc.1989-03-08
CLINISTAT HEMOGLOBIN REAGENT TEST (K885227)Heraeus Kulzer, Inc.1989-02-24
CLINISTAT TRIGLYCERIDES REAGENT TEST (K885134)Heraeus Kulzer, Inc.1989-02-10
CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN (K885144)Heraeus Kulzer, Inc.1989-02-02
CLINISTAT SGOT (AST) REAGENT TEST (K885156)Heraeus Kulzer, Inc.1989-02-02
CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST (K883327)Heraeus Kulzer, Inc.1989-01-23
CLINISTAT GLUCOSE REAGENT TEST (K884756)Heraeus Kulzer, Inc.1989-01-13
CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST (K883321)Heraeus Kulzer, Inc.1988-10-25
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