• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
New Search Back to Search Results
Device refractometer for donor testing
Regulation Description Refractometer for clinical use.
Definition For total protein testing of plasma donors to determine eligibility.
Physical State Standalone device
Technical Method Refraction index to determine total protein concentration
Target Area Testing of plasma
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodePSM
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(k)
Regulation Number 862.2800
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible