MAC · Class I · 21 CFR 878.4014

FDA Product Code MAC: Decontamination Kit

This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.pdf. 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
69d
Avg days
1989
Since

FDA 510(k) Cleared Decontamination Kit Devices (Product Code MAC)

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

About Product Code MAC - Regulatory Context