Horizon Diagnostics, Inc. - FDA 510(k) Cleared Devices
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Horizon Diagnostics, Inc. Chemistry ✕
7 devices
Cleared
Jul 14, 1997
CREATINE KINASE-MB REAGENT SET
Chemistry
76d
Cleared
Jun 13, 1996
HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT
Chemistry
1046d
Cleared
Sep 20, 1995
IRON/TIBC REAGENT
Chemistry
659d
Cleared
Apr 06, 1994
AMYLASE
Chemistry
421d
Cleared
Nov 26, 1993
BUN-300/BUN-500 UREA NITROGEN REAGENT
Chemistry
70d
Cleared
Jun 29, 1993
DIRECT BILIRUBIN
Chemistry
140d
Cleared
May 11, 1993
IN-VITRO DIAGNOSTIC REAGENT SET
Chemistry
124d