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

Fluorescent Immunoassay, Diphenylhydantoin

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

LES is the FDA product code for Fluorescent Immunoassay, Diphenylhydantoin, a class II device type, regulated under 21 CFR 862.3350. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LES
Device name
Fluorescent Immunoassay, Diphenylhydantoin
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
7
Ingested recalls
0

Clearances, product code LES

By decision year
7 clearances under product code LES with a decision year between 1980 and 1987, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LES by decision year
YearClearances
19801
19812
19821
19831
19851
19871

Applicants with the most clearances

Product code LES
Applicants holding the most 510(k) clearances under product code LES
ApplicantClearances
Miles Laboratories, Inc.2
American Dade1
American Diagnostic Corp.1
Sclavo, Inc.1
Syva Co.1
Syva Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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