Heraeus Kulzer, Inc. - FDA 510(k) Cleared Devices
145
Total
145
Cleared
0
Denied
53 devices
Cleared
Jun 01, 1995
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION
Chemistry
86d
Cleared
May 05, 1995
DCA 2000 SYSTEM FOR HEMOGLOBIN A1C
Chemistry
39d
Cleared
Feb 22, 1995
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER
Chemistry
64d
Cleared
Oct 31, 1994
NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000,...
Chemistry
89d
Cleared
Jun 13, 1994
GLUCOMETER ELITE LOW CONTROL
Chemistry
125d
Cleared
May 10, 1994
GLUCOFILM TEST STRIPS
Chemistry
133d
Cleared
Dec 07, 1993
GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION
Chemistry
55d
Cleared
Dec 07, 1993
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION
Chemistry
55d
Cleared
Nov 10, 1993
GLUCOSTIX REAGENT STRIPS
Chemistry
324d
Cleared
Nov 10, 1993
FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)
Chemistry
292d
Cleared
Sep 08, 1993
GLUCOFILM TEST STRIPS
Chemistry
261d
Cleared
Jun 25, 1993
GLUCOMETER M+ BLOOD GLUCOSE METER
Chemistry
102d
Looking for a specific device from Heraeus Kulzer, Inc.? Search by device name or K-number.
Search all Heraeus Kulzer, Inc. devices