Company · US
Maine Standards Co.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2017. Name variants (Inc, Corp, punctuation) are merged.
30510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 21, 2017 | K170864 | VALIDATE D-Dimer Calibration Verification / Linearity Test Kit Maine Standards Company, LLC | GGN |
| Mar 16, 2017 | K163498 | VALIDATE Heparin Calibration Verification/Linearity Test Kit Maine Standards Company, LLC | GGN |
| Jan 5, 2017 | K162705 | VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit Maine Standards Company, LLC | GGN |
| Jun 3, 2016 | K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test Kit Maine Standards Company, LLC | GGN |
| Apr 30, 2015 | K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test Kit Maine Standards Company, LLC | JJY |
| Feb 5, 2014 | K133550 | VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT Maine Standards Company, LLC | JJX |
| Jun 14, 2013 | K123127 | VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 Maine Standards Co. | JJX |
| Jan 27, 2012 | K113524 | VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT Maine Standards Co. | JJX |
| Jul 5, 2011 | K110880 | VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT Maine Standards Company, LLC | JJY |
| Jan 25, 2011 | K103271 | MSC LIPID CONTROL Maine Standards Co. | JJY |
| Jun 25, 2009 | K091225 | VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET Maine Standards Co. | JJY |
| Apr 16, 2009 | K090475 | VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402 Maine Standards Co. | JJY |
| Mar 23, 2009 | K083891 | VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 Maine Standards Co. | JJY |
| Aug 22, 2008 | K082067 | MSC LIPID CONTROL Maine Standards Co. | JJY |
| Sep 14, 2007 | K072246 | VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601 Maine Standards Co. | JJY |
| Sep 29, 2006 | K062501 | VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 Maine Standards Co. | JJX |
| Jan 13, 2006 | K053247 | VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET Maine Standards Co. | JJY |
| Mar 25, 2005 | K050504 | VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS Maine Standards Co. | JJY |
| Oct 15, 2004 | K041975 | VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501 Maine Standards Co. | JJY |
| Feb 27, 2004 | K033879 | VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 Maine Standards Co. | DKB |
| Jan 6, 2003 | K023410 | VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110 Maine Standards Co. | JJY |
| Nov 22, 2002 | K023352 | VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109 Maine Standards Co. | JJY |
| Mar 21, 2002 | K020450 | VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108 Maine Standards Co. | JJY |
| Nov 20, 2001 | K013265 | VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007 Maine Standards Co. | JJY |
| Nov 16, 2001 | K013119 | VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006 Maine Standards Co. | JJX |
| Aug 20, 2001 | K012122 | VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005 Maine Standards Co. | JJX |
| Aug 20, 2001 | K012120 | VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004 Maine Standards Co. | JJY |
| Aug 20, 2001 | K012119 | VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003 Maine Standards Co. | JJY |
| Aug 20, 2001 | K012118 | VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002 Maine Standards Co. | JJY |
| Aug 20, 2001 | K012117 | VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001 Maine Standards Co. | JJY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||