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

Enzyme Immunoassay, Oxcarbazepine Metabolite

21 CFR 862.3645 / Clinical Toxicology
FDA source (opens on fda.gov)

POX is the FDA product code for Enzyme Immunoassay, Oxcarbazepine Metabolite, a class II device type, regulated under 21 CFR 862.3645. FDA's definition for this code reads: "An Oxcarbazepine Metabolite Assay is an enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help ensure appropriate therapy". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
POX
Device name
Enzyme Immunoassay, Oxcarbazepine Metabolite
FDA definition
An Oxcarbazepine Metabolite Assay is an enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help ensure appropriate therapy.
Regulation
21 CFR 862.3645
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
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code POX

By decision year
1 clearance under product code POX with a decision year between 2016 and 2016, 2016 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code POX by decision year
YearClearances
20161

Applicants with the most clearances

Product code POX
Applicants holding the most 510(k) clearances under product code POX
ApplicantClearances
Ark Diagnostics Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code