FDA Product Code MLM: Enzyme Immunoassay, Tracrolimus
Leading manufacturers include Siemens Healthcare Diagnostics and Roche Diagnostics.
2
Total
2
Cleared
302d
Avg days
2015
Since
List of Enzyme Immunoassay, Tracrolimus devices cleared through 510(k)
2 devices
Cleared
Nov 06, 2018
Elecsys Tacrolimus
Roche Diagnostics
Toxicology
321d
Cleared
Nov 04, 2015
Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
Siemens Healthcare Diagnostics
Toxicology
282d
How to use this database
This page lists all FDA 510(k) submissions for Enzyme Immunoassay, Tracrolimus devices (product code MLM). 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 →