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

Gas Chromatography, Phenobarbital

21 CFR 862.3660 / Clinical Toxicology
FDA source (opens on fda.gov)

DJH is the FDA product code for Gas Chromatography, Phenobarbital, a class II device type, regulated under 21 CFR 862.3660. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
DJH
Device name
Gas Chromatography, Phenobarbital
Regulation
21 CFR 862.3660
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 DJH

By decision year
1 clearance under product code DJH with a decision year between 1984 and 1984, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DJH by decision year
YearClearances
19841

Applicants with the most clearances

Product code DJH
Applicants holding the most 510(k) clearances under product code DJH
ApplicantClearances
Siemens Elema AB1

Companies listing this code with FDA

Companies whose registered establishments list this code

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