LRS · Class II · 21 CFR 880.5200

FDA Product Code LRS: I.v. Start 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.

30
Total
30
Cleared
142d
Avg days
1976
Since

FDA 510(k) Cleared I.v. Start Kit Devices (Product Code LRS)

30 devices
1–24 of 30
No devices found for this product code.

About Product Code LRS - Regulatory Context