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

Thin Layer Chromatography, Cocaine

21 CFR 862.3250 / Clinical Toxicology
FDA source (opens on fda.gov)

DMN is the FDA product code for Thin Layer Chromatography, Cocaine, a class II device type, regulated under 21 CFR 862.3250. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DMN
Device name
Thin Layer Chromatography, Cocaine
Regulation
21 CFR 862.3250
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 DMN

By decision year
2 clearances under product code DMN with a decision year between 1989 and 1997, 1989 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DMN by decision year
YearClearances
19891
19971

Applicants with the most clearances

Product code DMN
Applicants holding the most 510(k) clearances under product code DMN
ApplicantClearances
Phamatech Inc.1
Sakers, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code