Medical Device Manufacturer · US , Windham , ME

Maine Standards Company, LLC

7 submissions · 7 cleared · Since 2011
7
Total
7
Cleared
0
Denied

Maine Standards Company, LLC has 7 FDA 510(k) cleared medical devices. Based in Windham, US.

Historical record: 7 cleared submissions from 2011 to 2017. Primary specialty: Hematology.

Browse the FDA 510(k) cleared devices submitted by Maine Standards Company, LLCFilter by specialty or product code using the sidebar.

7 devices
1–7 of 7
VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
K170864 · GGN Plasma, Coagulation Control · Hematology
Jun 2017 90d
VALIDATE Heparin Calibration Verification/Linearity Test Kit
K163498 · GGN Plasma, Coagulation Control · Hematology
Mar 2017 93d
VALIDATE? D-Dimer Calibration Verification/ Linearity Test Kit
K162705 · GGN Plasma, Coagulation Control · Hematology
Jan 2017 99d
VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
K152961 · GGN Plasma, Coagulation Control · Hematology
Jun 2016 240d
VALIDATE Anemia Calibration Verification/ Linearity Test Kit
K142964 · JJY Multi-analyte Controls, All Kinds (assayed) · Chemistry
Apr 2015 198d
VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT
K133550 · JJX Single (specified) Analyte Controls (assayed And Unassayed) · Chemistry
Feb 2014 78d
VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT
K110880 · JJY Multi-analyte Controls, All Kinds (assayed) · Chemistry
Jul 2011 97d
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