PSM

Refractometer For Donor Testing

Product code

PSM

Device name

Refractometer For Donor Testing

Device class

Class 1

21 CFR

21 CFR 862.2800

Medical specialty

Clinical Chemistry

Marketing pathway

510(K) Exempt

FDA classification definition

For total protein testing of plasma donors to determine eligibility.

Definition text from the FDA device classification database (U.S. federal government work, public domain).