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

Thin Layer Chromatography, Salicylate

21 CFR 862.3830 / Clinical Toxicology
FDA source (opens on fda.gov)

DJE is the FDA product code for Thin Layer Chromatography, Salicylate, a class II device type, regulated under 21 CFR 862.3830. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
DJE
Device name
Thin Layer Chromatography, Salicylate
Regulation
21 CFR 862.3830
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 DJE

By decision year
1 clearance under product code DJE with a decision year between 1980 and 1980, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DJE by decision year
YearClearances
19801

Applicants with the most clearances

Product code DJE
Applicants holding the most 510(k) clearances under product code DJE
ApplicantClearances
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 DJE.