Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 cyanomethemoglobin reagent and standard solution
Regulation Description Whole blood hemoglobin assays.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeGJZ
Submission Type 510(k)
Regulation Number 864.7500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm092800.htm] 
Third Party Review
Accredited Persons

-
-