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PSM — Refractometer For Donor Testing Class I

FDA Device Classification

FDA product code PSM covers "Refractometer For Donor Testing", a Class I medical device regulated under 21 CFR 862.2800. Submissions are reviewed by the Clinical Chemistry panel.

Classification Details

Product Code: PSM
Device Class: Class I
Regulation Number: 862.2800
Submission Type
Review Panel: CH
Medical Specialty: Clinical Chemistry
Implant: No

Definition

For total protein testing of plasma donors to determine eligibility.