Maine Standards Co.
Medical device manufacturer in Cumberland Foreside, ME.
30510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K170864 | VALIDATE D-Dimer Calibration Verification / Linearity Test KitGGN · Traditional | 06/21/2017SE |
| K163498 | VALIDATE Heparin Calibration Verification/Linearity Test KitGGN · Traditional | 03/16/2017SE |
| K162705 | VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitGGN · Traditional | 01/05/2017SE |
| K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test KitGGN · Traditional | 06/03/2016SE |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test KitJJY · Traditional | 04/30/2015SE |
| K133550 | Validate Ferritin Calibration Verification/ Linearity Test KitJJX · Traditional | 02/05/2014SE |
| K123127 | Validate Psa Calibration Verification/ Linearity Test Kit Model 406JJX · Traditional | 06/14/2013SE |
| K113524 | Validate Vit D Calibration Verification/ Linearity Test KitJJX · Traditional | 01/27/2012SE |
| K110880 | Validate (R) GC3 Calibration Verification / Linearity Test KitJJY · Traditional | 07/05/2011SE |
| K103271 | MSC Lipid ControlJJY · Traditional | 01/25/2011SE |
| K091225 | Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test SetJJY · Traditional | 06/25/2009SE |
| K090475 | Validate CM2 Calibration Verification / Linearity Test Set, Model 402JJY · Traditional | 04/16/2009SE |
| K083891 | Validate Thyroid Calibration Verification Test Set, Model 901JJY · Traditional | 03/23/2009SE |
| K082067 | MSC Lipid ControlJJY · Traditional | 08/22/2008SE |
| K072246 | Validate SP1 Calibration Verification/Linearity Test Set, Model 601JJY · Traditional | 09/14/2007SE |
| K062501 | Validate Thyroid Calibration Verification / Linearity Test Set, Model 901JJX · Traditional | 09/29/2006SE |
| K053247 | Validate Cardiac Marker (CM1) Calibration Verification Test SetJJY · Traditional | 01/13/2006SE |
| K050504 | Validate Urine Chemistry Calibration Verification Test SetsJJY · Traditional | 03/25/2005SE |
| K041975 | Validate Lipoprotein Calibration Verification Test Set, Model 501JJY · Traditional | 10/15/2004SE |
| K033879 | Validate TDM Calibration Verification Test Set, Model 126DKB · Traditional | 02/27/2004SE |
| K023410 | Validate Chem 10 Calibration Verification Test Set, Model 110JJY · Traditional | 01/06/2003SE |
| K023352 | Validate Chem 9 Calibration Verification Test Set, Model 109JJY · Traditional | 11/22/2002SE |
| K020450 | Validate Chem 8 Calibration Verification Test Set; Model 108JJY · Traditional | 03/21/2002SE |
| K013265 | Validate Chem 7 Calibration Verification Test Set, Model 10007JJY · Traditional | 11/20/2001SE |
| K013119 | Validate Chem 6 Calibration Verification Test Set Model # 10006JJX · Traditional | 11/16/2001SE |
| K012122 | Validate Chem 5 Calibration Verification Test Set, Model 10005JJX · Traditional | 08/20/2001SE |
| K012120 | Validate Chem 4 Calibration Verification Test Set, Model 10004JJY · Traditional | 08/20/2001SE |
| K012119 | Validate Chem 3 Calibration Verification Test Set, Model 10003JJY · Traditional | 08/20/2001SE |
| K012118 | Validate Chem 2 Calibration Verification Test Set, Model 10002JJY · Traditional | 08/20/2001SE |
| K012117 | Validate Chem 1 Calibration Verification Test Set, Model 10001JJY · Traditional | 08/20/2001SE |