Hichem Diagnostics - FDA 510(k) Cleared Devices
41
Total
41
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hichem Diagnostics Chemistry ✕
41 devices
Cleared
Jul 29, 1998
HICHEM CALCIUM REAGENT KIT
Chemistry
69d
Cleared
Sep 23, 1996
HICHEM ALP/AMP REAGENT KIT
Chemistry
27d
Cleared
Sep 06, 1995
HICHEM ISE DILUENT KIT 70008
Chemistry
20d
Cleared
Sep 06, 1995
HICHEM ISE INTDERNAL REFERENCE KIT 70009
Chemistry
20d
Cleared
Sep 06, 1995
HICHEM ISEKCI SOLUTION KIT 70010
Chemistry
20d
Cleared
Sep 06, 1995
HICHEM ISE STANDARDS KIT 70011
Chemistry
20d
Cleared
Aug 02, 1995
HICHEM AST REAGENT KIT
Chemistry
107d
Cleared
May 02, 1995
HICHEM Y-GT REAGENT KIT
Chemistry
133d
Cleared
Feb 23, 1995
HICHEM LDH/L REAGENT KIT
Chemistry
73d
Cleared
Aug 02, 1994
HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH
Chemistry
131d
Cleared
Apr 20, 1993
HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806
Chemistry
168d
Cleared
Apr 20, 1993
HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807
Chemistry
168d
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