MLM · Class II · 21 CFR 862.1678

FDA Product Code MLM: Enzyme Immunoassay, Tracrolimus

Leading manufacturers include Siemens Healthcare Diagnostics, Roche Diagnostics and Shanghai Genext Medical Technology Co., Ltd..

9
Total
9
Cleared
230d
Avg days
2005
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Enzyme Immunoassay, Tracrolimus Devices (Product Code MLM)

9 devices
1–9 of 9
Cleared Jan 27, 2023
Tacrolimus Assay Kit
K203833
Shanghai Genext Medical Technology Co., Ltd.
Chemistry · 758d
Cleared Nov 06, 2018
Elecsys Tacrolimus
K173857
Roche Diagnostics
Toxicology · 321d
Cleared Nov 04, 2015
Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
K150168
Siemens Healthcare Diagnostics
Toxicology · 282d

About Product Code MLM - Regulatory Context

510(k) Submission Activity

9 total 510(k) submissions under product code MLM since 2005, with 9 receiving FDA clearance (average review time: 230 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

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