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. has 23 FDA 510(k) cleared chemistry devices. Based in Windham, US.

Historical record: 23 cleared submissions from 2001 to 2013.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

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

23 devices
1-23 of 23
Cleared Jun 14, 2013
VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406
K123127 · JJX
Immunology · 253d
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 14, 2007
VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601
K072246 · JJY
Immunology · 32d
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 Feb 27, 2004
VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126
K033879 · DKB
Toxicology · 74d
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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