Maine Standards Company, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K170864 | VALIDATE D-Dimer Calibration Verification / Linearity Test Kit | June 21, 2017 |
| K163498 | VALIDATE Heparin Calibration Verification/Linearity Test Kit | March 16, 2017 |
| K162705 | VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit | January 5, 2017 |
| K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test Kit | June 3, 2016 |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test Kit | April 30, 2015 |
| K133550 | VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT | February 5, 2014 |
| K110880 | VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT | July 5, 2011 |