FirmLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Maine Standards Company with 30 510(k) clearances. The most recent is a 510(k) clearance dated Jun 21, 2017: VALIDATE D-Dimer Calibration Verification / Linearity Test Kit.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 21, 2017 | VALIDATE D-Dimer Calibration Verification / Linearity Test KitK170864 · GGN | 510(k) clearances |
| Mar 16, 2017 | VALIDATE Heparin Calibration Verification/Linearity Test KitK163498 · GGN | 510(k) clearances |
| Jan 5, 2017 | VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitK162705 · GGN | 510(k) clearances |
| Jun 3, 2016 | VALIDATE D-Dimer Calibration Verification/Linearity Test KitK152961 · GGN | 510(k) clearances |
| Apr 30, 2015 | VALIDATE Anemia Calibration Verification/ Linearity Test KitK142964 · JJY | 510(k) clearances |
| Feb 5, 2014 | VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KITK133550 · JJX | 510(k) clearances |
| Jun 14, 2013 | VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406K123127 · JJX | 510(k) clearances |
| Jan 27, 2012 | VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KITK113524 · JJX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
