Maine Standards Co.
Windham, ME, US
Maine Standards Co. appears in FDA device records in Windham, ME. FDA records list 30 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 30
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 30 510(k) clearances for Maine Standards Co. between 2001 and 2017. The busiest year on record is 2001, with 7. The most recent is 2017, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 7 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 3 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K170864 | VALIDATE D-Dimer Calibration Verification / Linearity Test Kit | GGN | Substantially Equivalent | |
| K163498 | VALIDATE Heparin Calibration Verification/Linearity Test Kit | GGN | Substantially Equivalent | |
| K162705 | VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit | GGN | Substantially Equivalent | |
| K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test Kit | GGN | Substantially Equivalent | |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test Kit | JJY | Substantially Equivalent | |
| K133550 | VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT | JJX | Substantially Equivalent | |
| K123127 | VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 | JJX | Substantially Equivalent | |
| K113524 | VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT | JJX | Substantially Equivalent | |
| K110880 | VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT | JJY | Substantially Equivalent | |
| K103271 | MSC LIPID CONTROL | JJY | Substantially Equivalent | |
| K091225 | VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET | JJY | Substantially Equivalent | |
| K090475 | VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402 | JJY | Substantially Equivalent | |
| K083891 | VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 | JJY | Substantially Equivalent | |
| K082067 | MSC LIPID CONTROL | JJY | Substantially Equivalent | |
| K072246 | VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601 | JJY | Substantially Equivalent | |
| K062501 | VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 | JJX | Substantially Equivalent | |
| K053247 | VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET | JJY | Substantially Equivalent | |
| K050504 | VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS | JJY | Substantially Equivalent | |
| K041975 | VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501 | JJY | Substantially Equivalent | |
| K033879 | VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 | DKB | Substantially Equivalent | |
| K023410 | VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110 | JJY | Substantially Equivalent | |
| K023352 | VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109 | JJY | Substantially Equivalent | |
| K020450 | VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108 | JJY | Substantially Equivalent | |
| K013265 | VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007 | JJY | Substantially Equivalent | |
| K013119 | VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006 | JJX | Substantially Equivalent | |
| K012122 | VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005 | JJX | Substantially Equivalent | |
| K012120 | VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004 | JJY | Substantially Equivalent | |
| K012119 | VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003 | JJY | Substantially Equivalent | |
| K012118 | VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002 | JJY | Substantially Equivalent | |
| K012117 | VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001 | JJY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain