Hichem Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
41
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K981794HICHEM CALCIUM REAGENT KITJuly 29, 1998
K963383HICHEM ALP/AMP REAGENT KITSeptember 23, 1996
K953863HICHEM ISE STANDARDS KIT 70011September 6, 1995
K953861HICHEM ISE INTDERNAL REFERENCE KIT 70009September 6, 1995
K953862HICHEM ISEKCI SOLUTION KIT 70010September 6, 1995
K953860HICHEM ISE DILUENT KIT 70008September 6, 1995
K951751HICHEM AST REAGENT KITAugust 2, 1995
K946192HICHEM Y-GT REAGENT KITMay 2, 1995
K946022HICHEM LDH/L REAGENT KITFebruary 23, 1995
K941433HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGHAugust 2, 1994
K925612HI CHEM ELECTROLYTE BUFFERApril 20, 1993
K925551HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807April 20, 1993
K925550HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806April 20, 1993
K925611HI CHEM ELECTROLYTE REFERENCE REAGENTFebruary 23, 1993
K925553HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813February 12, 1993
K925552HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812February 12, 1993
K913792HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROLSeptember 25, 1991
K911803HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIEDMay 15, 1991
K904099URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDSOctober 26, 1990
K904293HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237)October 12, 1990