Medical Device Manufacturer · US , Windham , ME

Maine Standards Co. - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 2001
23
Total
23
Cleared
0
Denied

Maine Standards Co. — FDA 510(k) Products and Clearance History Chemistry

20 devices
1-20 of 20
Cleared Jan 27, 2012
VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT
K113524 · JJX
Chemistry · 59d
Cleared Jan 25, 2011
MSC LIPID CONTROL
K103271 · JJY
Chemistry · 81d
Cleared Jun 25, 2009
VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET
K091225 · JJY
Chemistry · 59d
Cleared Apr 16, 2009
VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402
K090475 · JJY
Chemistry · 51d
Cleared Mar 23, 2009
VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901
K083891 · JJY
Chemistry · 84d
Cleared Aug 22, 2008
MSC LIPID CONTROL
K082067 · JJY
Chemistry · 31d
Cleared Sep 29, 2006
VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901
K062501 · JJX
Chemistry · 35d
Cleared Jan 13, 2006
VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET
K053247 · JJY
Chemistry · 53d
Cleared Mar 25, 2005
VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS
K050504 · JJY
Chemistry · 25d
Cleared Oct 15, 2004
VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501
K041975 · JJY
Chemistry · 85d
Cleared Jan 06, 2003
VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110
K023410 · JJY
Chemistry · 88d
Cleared Nov 22, 2002
VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109
K023352 · JJY
Chemistry · 46d
Cleared Mar 21, 2002
VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET
K020450 · JJY
Chemistry · 38d
Cleared Nov 20, 2001
VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007
K013265 · JJY
Chemistry · 50d
Cleared Nov 16, 2001
VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006
K013119 · JJX
Chemistry · 59d
Cleared Aug 20, 2001
VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001
K012117 · JJY
Chemistry · 45d
Cleared Aug 20, 2001
VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002
K012118 · JJY
Chemistry · 45d
Cleared Aug 20, 2001
VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003
K012119 · JJY
Chemistry · 45d
Cleared Aug 20, 2001
VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004
K012120 · JJY
Chemistry · 45d
Cleared Aug 20, 2001
VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005
K012122 · JJX
Chemistry · 45d
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