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 kit, test, pregnancy, hcg, over the counter
Regulation Description Human chorionic gonadotropin (HCG) test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeLCX
Submission Type 510(k)
Regulation Number 862.1155
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm092791.htm] 
Third Party Review Not Third Party Eligible
-
-