CBT · Class I · 21 CFR 868.1100

FDA Product Code CBT: Arterial Blood Sampling 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.

58
Total
58
Cleared
83d
Avg days
1977
Since

FDA 510(k) Cleared Arterial Blood Sampling Kit Devices (Product Code CBT)

58 devices
1–24 of 58
No devices found for this product code.

About Product Code CBT - Regulatory Context