What Is This Device?
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
What Is FDA Product Code OHL?
Pap Smear Kit is FDA product code OHL, Class 2, 21 CFR 884.4530.
What Does It Take to Sell It in the United States?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.