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

Gas Chromatography, Morphine

21 CFR 862.3640 / Clinical Toxicology
FDA source (opens on fda.gov)

DMY is the FDA product code for Gas Chromatography, Morphine, a class II device type, regulated under 21 CFR 862.3640. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
DMY
Device name
Gas Chromatography, Morphine
Regulation
21 CFR 862.3640
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 DMY

By decision year
1 clearance under product code DMY with a decision year between 1999 and 1999, 1999 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DMY by decision year
YearClearances
19991

Applicants with the most clearances

Product code DMY
Applicants holding the most 510(k) clearances under product code DMY
ApplicantClearances
Roche Diagnostics GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code

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