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

Everolimus Immunoassay

21 CFR 862.3840 / Clinical Toxicology
FDA source (opens on fda.gov)

OUF is the FDA product code for Everolimus Immunoassay, a class II device type, regulated under 21 CFR 862.3840. FDA's definition for this code reads: "To quantify everolimus in whole blood". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OUF
Device name
Everolimus Immunoassay
FDA definition
To quantify everolimus in whole blood.
Regulation
21 CFR 862.3840
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code OUF

By decision year
2 clearances under product code OUF with a decision year between 2011 and 2013, 2011 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OUF by decision year
YearClearances
20111
20131

Applicants with the most clearances

Product code OUF
Applicants holding the most 510(k) clearances under product code OUF
ApplicantClearances
Microgenics Corporation2

Companies listing this code with FDA

Companies whose registered establishments list this code