DIS · Class II · 21 CFR 862.3150

FDA Product Code DIS: Enzyme Immunoassay, Barbiturate

Leading manufacturers include Healgen Scientific, LLC and Immunalysis Corporation.

100
Total
100
Cleared
97d
Avg days
1979
Since

FDA 510(k) Cleared Enzyme Immunoassay, Barbiturate Devices (Product Code DIS)

100 devices
1–24 of 100
Cleared Oct 14, 2016
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K161714
Immunalysis Corporation
Toxicology · 115d
Cleared Apr 24, 2015
Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
K150791
Healgen Scientific, LLC
Toxicology · 30d

About Product Code DIS - Regulatory Context

DIS devices are reviewed by the Toxicology panel. Browse all Toxicology devices →