Catachem, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
41
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K062503CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KITJanuary 19, 2007
K945408340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZERFebruary 22, 1995
K932871UIBC FOR DISCREET RANDOM ACCESS ANALYZERSeptember 8, 1993
K903341MAGNESIUMAugust 22, 1990
K902326AMYLASE FOR MANUAL/AUTOMATED APPLICATIONSJuly 31, 1990
K902877TOTAL IRON FOR MANUAL/AUTOMATEDJuly 27, 1990
K895748BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONSDecember 21, 1989
K895821URIC ACID FOR MANUAL/AUTOMATED APPLICATIONSDecember 5, 1989
K894715CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONSNovember 8, 1989
K894476CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATIONOctober 12, 1989
K894389CREATININE FOR MANUAL OR AUTOMATED APPLICATIONSOctober 12, 1989
K894173BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICATSeptember 5, 1989
K892668TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONSJuly 20, 1989
K893884BACTON TM, BASIC TM, APO B REAGENTJune 21, 1989
K893885BACTON TM, BASIC TM, APO A-I REAGENTJune 21, 1989
K892905DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.June 19, 1989
K891240DIRECT BILIRUBIN FOR CONTINUOUS FLOWMay 10, 1989
K891025TOTAL BILIRUBIN FOR CONTINUOUS FLOWApril 4, 1989
K884724ASPARTATE AMINOTRANSFERASE (AST)March 8, 1989
K884936ALANINE AMINOTRANSFERASEJanuary 3, 1989