Medical Device Manufacturer · US , Windham , ME

Maine Standards Co. - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 2001

23

Total

23

Cleared

0

Denied

FDA 510(k) Regulatory Record - Maine Standards Co. Immunology ✕

2 devices

1-2 of 2

Cleared Jun 14, 2013

VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406

Immunology · 253d

Cleared Sep 14, 2007

VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601

Immunology · 32d