510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PSMClass I

Refractometer For Donor Testing

21 CFR 862.2800 / Clinical Chemistry
FDA source (opens on fda.gov)

PSM is the FDA product code for Refractometer For Donor Testing, a class I device type, regulated under 21 CFR 862.2800. FDA's definition for this code reads: "For total protein testing of plasma donors to determine eligibility". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PSM
Device name
Refractometer For Donor Testing
FDA definition
For total protein testing of plasma donors to determine eligibility.
Regulation
21 CFR 862.2800
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code