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

Thin Layer Chromatography, Diphenylhydantoin

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

DPE is the FDA product code for Thin Layer Chromatography, Diphenylhydantoin, a class II device type, regulated under 21 CFR 862.3350. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
DPE
Device name
Thin Layer Chromatography, 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
1
Ingested recalls
0

Clearances, product code DPE

By decision year
1 clearance under product code DPE with a decision year between 1979 and 1979, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DPE by decision year
YearClearances
19791

Applicants with the most clearances

Product code DPE
Applicants holding the most 510(k) clearances under product code DPE
ApplicantClearances
Technicon Instruments 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 DPE.