510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MLMClass II

Enzyme Immunoassay, Tracrolimus

21 CFR 862.1678 / Clinical Chemistry
FDA source (opens on fda.gov)

MLM is the FDA product code for Enzyme Immunoassay, Tracrolimus, a class II device type, regulated under 21 CFR 862.1678. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 12 recalls.

Classification record

Product code
MLM
Device name
Enzyme Immunoassay, Tracrolimus
Regulation
21 CFR 862.1678
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
9
Ingested recalls
12

Clearances, product code MLM

By decision year
9 clearances under product code MLM with a decision year between 2005 and 2023, 2006 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MLM by decision year
YearClearances
20051
20062
20072
20131
20151
20181
20231

Applicants with the most clearances

Product code MLM
Applicants holding the most 510(k) clearances under product code MLM
ApplicantClearances
Siemens Healthcare Diagnostics Inc.3
Microgenics Corporation2
Fujirebio Diagnostics, Inc.1
Roche Diagnostics GmbH1
Shanghai Genext Medical Technology Co., Ltd.1
Waters Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code