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Maine Standards Co.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Known Names

maine standards company, maine standards

Recent 510(k) Clearances

K-NumberDeviceDate
K123127VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406June 14, 2013
K113524VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KITJanuary 27, 2012
K103271MSC LIPID CONTROLJanuary 25, 2011
K091225VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SETJune 25, 2009
K090475VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402April 16, 2009
K083891VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901March 23, 2009
K082067MSC LIPID CONTROLAugust 22, 2008
K072246VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601September 14, 2007
K062501VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901September 29, 2006
K053247VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SETJanuary 13, 2006
K050504VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETSMarch 25, 2005
K041975VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501October 15, 2004
K033879VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126February 27, 2004
K023410VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110January 6, 2003
K023352VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109November 22, 2002
K020450VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108March 21, 2002
K013265VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007November 20, 2001
K013119VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006November 16, 2001
K012122VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005August 20, 2001
K012118VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002August 20, 2001