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
53 devices
51-53 of 53
Cleared Jan 23, 1989
CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST
K883327 · JGZ
Chemistry · 168d
Cleared Jan 13, 1989
CLINISTAT GLUCOSE REAGENT TEST
K884756 · CGA
Chemistry · 60d
Cleared Oct 25, 1988
CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST
K883321 · JJE
Chemistry · 81d
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