MLM · Class II · 21 CFR 862.1678

FDA Product Code MLM: Enzyme Immunoassay, Tracrolimus

Leading manufacturers include Microgenics Corp., Dade Behring, Inc. and Siemens Healthcare Diagnostics.

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
Cleared Jul 11, 2013
THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
K123343
Microgenics Corp.
Toxicology · 253d
Cleared May 18, 2006
DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107
K060502
Dade Behring, Inc.
Toxicology · 83d
Cleared Apr 06, 2006
EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT
K060385
Dade Behring, Inc.
Chemistry · 51d
Cleared Mar 15, 2005
CEDIA TACROLIMUS ASSAY
K050206
Microgenics Corp.
Toxicology · 46d

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.