DeviceClearance

Product code MLM— Clinical Chemistry

ARCHITECT TACROLIMUS: MODEL 1L77

Classification name
Enzyme Immunoassay, Tracrolimus
Device class
Class 2
Regulation
21 CFR 862.1678
Advisory panel
Clinical Chemistry
Total cleared
9
First cleared
Most recent

Market context for product code MLM

FDA has cleared 9 devices under product code MLM between 2005 and 2023, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code MLM

Recent clearances under product code MLM

Data sourced from openFDA. This site is unofficial and independent of the FDA.