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Quantimetrix Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
38
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K142262AUTION CHECK PLUSApril 10, 2015
K113177COMPLETE D 25-OH VITAMIN D CONTROLMay 10, 2012
K103744DROPPER A1C DIABETES CONTROLMay 12, 2011
K062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLOctober 30, 2006
K062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKEROctober 3, 2006
K060417MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROLMarch 21, 2006
K032791GLYCOHEMOSURE HBA1C CONTROLOctober 30, 2003
K030826PRECISET DAT AMPHETAMINEApril 3, 2003
K021393PRECISET DAT PLUSJune 13, 2002
K013662MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONSMarch 8, 2002
K010337LIPOPRINT SYSTEM, LDL SUBFRACTIONSJuly 25, 2001
K010598SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROLMarch 23, 2001
K993723CARDIASURE CARDIAC MARKERS CONTROLNovember 23, 1999
K973894IMMUSUREOctober 29, 1997
K970862SPINALSCOPICSApril 8, 1997
K943394PROSTAT CONTROLMay 23, 1995
K943925SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTINGOctober 4, 1994
K941130ASSURE URINE HCG CONTROLJune 3, 1994
K932623QUANTIMETRIX BLOOD GLUCOSE CONTROLSDecember 9, 1993
K931523QUANTIMETRIX C-CLEAR(TM)June 25, 1993