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

Gas Chromatography, Diphenylhydantoin

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

DKH is the FDA product code for Gas Chromatography, Diphenylhydantoin, a class II device type, regulated under 21 CFR 862.3350. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DKH
Device name
Gas 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
2
Ingested recalls
0

Clearances, product code DKH

By decision year
2 clearances under product code DKH with a decision year between 1978 and 1980, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DKH by decision year
YearClearances
19781
19801

Applicants with the most clearances

Product code DKH
Applicants holding the most 510(k) clearances under product code DKH
ApplicantClearances
E.I. Dupont de Nemours & Co., Inc.1
Vitek Systems, 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 DKH.