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

Levetiracetam Assay

21 CFR 862.3350 / Clinical Toxicology
FDA source (opens on fda.gov)

ORI is the FDA product code for Levetiracetam Assay, a class II device type, regulated under 21 CFR 862.3350. FDA's definition for this code reads: "For the quantitative determination of levetiracetam in human serum or plasma". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ORI
Device name
Levetiracetam Assay
FDA definition
For the quantitative determination of levetiracetam in human serum or plasma.
Regulation
21 CFR 862.3350
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
2
Ingested recalls
0

Clearances, product code ORI

By decision year
2 clearances under product code ORI with a decision year between 2009 and 2024, 2009 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ORI by decision year
YearClearances
20091
20241

Applicants with the most clearances

Product code ORI
Applicants holding the most 510(k) clearances under product code ORI
ApplicantClearances
Ark Diagnostics Inc2

Companies listing this code with FDA

Companies whose registered establishments list this code