FDA Product Code DIS: Enzyme Immunoassay, Barbiturate
Leading manufacturers include Healgen Scientific, LLC and Immunalysis Corporation.
2
Total
2
Cleared
73d
Avg days
2015
Since
List of Enzyme Immunoassay, Barbiturate devices cleared through 510(k)
2 devices
Cleared
Oct 14, 2016
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
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)
Healgen Scientific, LLC
Toxicology
30d
How to use this database
This page lists all FDA 510(k) submissions for Enzyme Immunoassay, Barbiturate devices (product code DIS). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Toxicology FDA review panel. Browse all Toxicology devices →