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Maine Standards Co.

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K123127 VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406JJX2013-06-14 View
510(k) K113524 VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KITJJX2012-01-27 View
510(k) K103271 MSC LIPID CONTROLJJY2011-01-25 View
510(k) K091225 VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SETJJY2009-06-25 View
510(k) K090475 VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402JJY2009-04-16 View
510(k) K083891 VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901JJY2009-03-23 View
510(k) K082067 MSC LIPID CONTROLJJY2008-08-22 View
510(k) K072246 VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601JJY2007-09-14 View
510(k) K062501 VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901JJX2006-09-29 View
510(k) K053247 VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SETJJY2006-01-13 View
510(k) K050504 VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETSJJY2005-03-25 View
510(k) K041975 VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501JJY2004-10-15 View
510(k) K033879 VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126DKB2004-02-27 View
510(k) K023410 VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110JJY2003-01-06 View
510(k) K023352 VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109JJY2002-11-22 View
510(k) K020450 VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108JJY2002-03-21 View
510(k) K013265 VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007JJY2001-11-20 View
510(k) K013119 VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006JJX2001-11-16 View
510(k) K012122 VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005JJX2001-08-20 View
510(k) K012119 VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003JJY2001-08-20 View
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