Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Maine Standards Company, LLC

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K170864	VALIDATE D-Dimer Calibration Verification / Linearity Test Kit	GGN	2017-06-21	View
510(k)	K163498	VALIDATE Heparin Calibration Verification/Linearity Test Kit	GGN	2017-03-16	View
510(k)	K162705	VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit	GGN	2017-01-05	View
510(k)	K152961	VALIDATE D-Dimer Calibration Verification/Linearity Test Kit	GGN	2016-06-03	View
510(k)	K110880	VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT	JJY	2011-07-05	View

↑