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

Gabapentin Assay

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

OTF is the FDA product code for Gabapentin Assay, a class II device type, regulated under 21 CFR 862.3350. FDA's definition for this code reads: "Test for the quantitative determination of gabapentin in human serum or plasma. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OTF
Device name
Gabapentin Assay
FDA definition
Test for the quantitative determination of gabapentin in human serum or plasma. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin.
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
1
Ingested recalls
0

Clearances, product code OTF

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

Applicants with the most clearances

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

Companies listing this code with FDA

Companies whose registered establishments list this code