FDA product code LTY: Fluid, Cytological Collection

LTY is the FDA product code for fluid, cytological collection. It is a Class III device, reviewed by the Obstetrics and Gynecology panel. Devices under LTY reach the market by PMA; FDA lists no cleared 510(k)s for it.

Classification

FieldValue
Device nameFluid, Cytological Collection
Device classClass III
Review panelOB — Obstetrics and Gynecology
Medical specialtyUnknown
Premarket routePMA

Recalls for LTY devices

openFDA lists no recalls for product code LTY.

Frequently asked questions

What is FDA product code LTY?

LTY is the FDA product code for fluid, cytological collection. It is a Class III device, reviewed by the Obstetrics and Gynecology panel.

What device class is LTY?

Class III. Typical premarket route: PMA.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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