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

Thin Layer Chromatography, Opiates

21 CFR 862.3650 / Clinical Toxicology
FDA source (opens on fda.gov)

LAI is the FDA product code for Thin Layer Chromatography, Opiates, a class II device type, regulated under 21 CFR 862.3650. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
LAI
Device name
Thin Layer Chromatography, Opiates
Regulation
21 CFR 862.3650
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 LAI

By decision year
1 clearance under product code LAI with a decision year between 1993 and 1993, 1993 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LAI by decision year
YearClearances
19931

Applicants with the most clearances

Product code LAI
Applicants holding the most 510(k) clearances under product code LAI
ApplicantClearances
Toxi-Lab, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LAI.