Heraeus Kulzer, Inc. - FDA 510(k) Cleared Devices
145
Total
145
Cleared
0
Denied
145 devices
Cleared
May 11, 1993
CHEK-STIX CONTROL STRIPS FOR URINALYSIS
Toxicology
48d
Cleared
Apr 20, 1993
CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO
Toxicology
95d
Cleared
Apr 08, 1993
MATRIX CR 2050, PMI 3000
Radiology
169d
Cleared
Jan 28, 1993
CLINITEK 200+ URINE CHEMISTRY ANALYZER
Chemistry
38d
Cleared
Jan 27, 1993
URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS
Chemistry
51d
Cleared
Dec 17, 1992
ELITE TEST STRIPS GLUCOMETER
Chemistry
104d
Cleared
Nov 25, 1992
TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1
Chemistry
97d
Cleared
Nov 17, 1992
ORTHO WAX
Dental
98d
Cleared
Nov 04, 1992
PALABOND
Dental
64d
Cleared
Oct 14, 1992
TECHNICON DAX SYSTEM THYROXINE (T4) METHOD
Chemistry
118d
Cleared
Sep 29, 1992
PALADISC LC
Dental
75d
Cleared
Sep 28, 1992
MILES URINE AMYLASE METHOD
Chemistry
101d
Cleared
Sep 23, 1992
ENCORE TEST STRIPS
Chemistry
92d
Cleared
Sep 23, 1992
TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE
Chemistry
83d
Cleared
Sep 22, 1992
MILES SODIUM METHOD
Chemistry
95d
Cleared
Sep 22, 1992
MILES AUTO METH DETERMIN OF URIC ACID IN URINE
Chemistry
36d
Cleared
Sep 16, 1992
PALADUR
Dental
309d
Cleared
Sep 15, 1992
MILES URINE CALCIUM METHOD
Chemistry
88d
Cleared
Sep 15, 1992
MILES URINE GLUCOSE METHOD
Chemistry
88d
Cleared
Sep 11, 1992
TECHNICON H*2
Hematology
71d
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
Jul 16, 1992
SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)
Toxicology
83d
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