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

High Pressure Liquid Chromatography, Codeine

21 CFR 862.3270 / Clinical Toxicology
FDA source (opens on fda.gov)

LAE is the FDA product code for High Pressure Liquid Chromatography, Codeine, a class II device type, regulated under 21 CFR 862.3270. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LAE
Device name
High Pressure Liquid Chromatography, Codeine
Regulation
21 CFR 862.3270
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 LAE

By decision year
2 clearances under product code LAE with a decision year between 1983 and 1985, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LAE by decision year
YearClearances
19831
19851

Applicants with the most clearances

Product code LAE
Applicants holding the most 510(k) clearances under product code LAE
ApplicantClearances
Mem, Inc.1
Vygon Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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