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

Lamotrigine Assay

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

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

Classification record

Product code
ORH
Device name
Lamotrigine Assay
FDA definition
for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers.
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 ORH

By decision year
2 clearances under product code ORH with a decision year between 2007 and 2010, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ORH by decision year
YearClearances
20071
20101

Applicants with the most clearances

Product code ORH
Applicants holding the most 510(k) clearances under product code ORH
ApplicantClearances
Ark Diagnostics Inc1
Seradyn, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code