FCD · Class I · 21 CFR 876.5210

FDA Product Code FCD: Barium Enema Kit

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.

2
Total
2
Cleared
53d
Avg days
1987
Since

FDA 510(k) Cleared Barium Enema Kit Devices (Product Code FCD)

2 devices
1–2 of 2
No devices found for this product code.

About Product Code FCD - Regulatory Context