Medical Device Manufacturer · US , Elkhart , IN

Heraeus Kulzer, Inc. - FDA 510(k) Cleared Devices

145 submissions · 145 cleared · Since 1988
145
Total
145
Cleared
0
Denied
145 devices
76-100 of 145
Cleared May 11, 1993
CHEK-STIX CONTROL STRIPS FOR URINALYSIS
K931467 · JJW
Toxicology · 48d
Cleared Apr 20, 1993
CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO
K930208 · DLI
Toxicology · 95d
Cleared Apr 08, 1993
MATRIX CR 2050, PMI 3000
K925289 · LMC
Radiology · 169d
Cleared Jan 28, 1993
CLINITEK 200+ URINE CHEMISTRY ANALYZER
K926359 · KQO
Chemistry · 38d
Cleared Jan 27, 1993
URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS
K926144 · JGJ
Chemistry · 51d
Cleared Dec 17, 1992
ELITE TEST STRIPS GLUCOMETER
K924499 · CGA
Chemistry · 104d
Cleared Nov 25, 1992
TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1
K925203 · JJQ
Chemistry · 97d
Cleared Nov 17, 1992
ORTHO WAX
K924024 · EGD
Dental · 98d
Cleared Nov 04, 1992
PALABOND
K924422 · EBI
Dental · 64d
Cleared Oct 14, 1992
TECHNICON DAX SYSTEM THYROXINE (T4) METHOD
K922945 · CDX
Chemistry · 118d
Cleared Sep 29, 1992
PALADISC LC
K923549 · EBH
Dental · 75d
Cleared Sep 28, 1992
MILES URINE AMYLASE METHOD
K923105 · JFJ
Chemistry · 101d
Cleared Sep 23, 1992
ENCORE TEST STRIPS
K923018 · CFR
Chemistry · 92d
Cleared Sep 23, 1992
TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE
K923258 · CDP
Chemistry · 83d
Cleared Sep 22, 1992
MILES SODIUM METHOD
K923037 · JOS
Chemistry · 95d
Cleared Sep 22, 1992
MILES AUTO METH DETERMIN OF URIC ACID IN URINE
K924129 · KNK
Chemistry · 36d
Cleared Sep 16, 1992
PALADUR
K915898 · EBI
Dental · 309d
Cleared Sep 15, 1992
MILES URINE CALCIUM METHOD
K923034 · CIC
Chemistry · 88d
Cleared Sep 15, 1992
MILES URINE GLUCOSE METHOD
K923040 · CFR
Chemistry · 88d
Cleared Sep 11, 1992
TECHNICON H*2
K923237 · GKZ
Hematology · 71d
Cleared Sep 09, 1992
MILES URINE UREA NITROGEN METHOD
K923035 · CDQ
Chemistry · 82d
Cleared Sep 09, 1992
URINE CHLORIDE
K923036 · CHJ
Chemistry · 82d
Cleared Aug 24, 1992
MILES POTASSIUM METHOD
K923038 · CEM
Chemistry · 66d
Cleared Aug 24, 1992
MILES URINE CREATININE METHOD
K923039 · CGX
Chemistry · 66d
Cleared Jul 16, 1992
SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)
K921939 · LAS
Toxicology · 83d

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