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

Thin Layer Chromatography, Barbiturate

21 CFR 862.3150 / Clinical Toxicology
FDA source (opens on fda.gov)

DKX is the FDA product code for Thin Layer Chromatography, Barbiturate, a class II device type, regulated under 21 CFR 862.3150. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DKX
Device name
Thin Layer Chromatography, Barbiturate
Regulation
21 CFR 862.3150
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 DKX

By decision year
2 clearances under product code DKX with a decision year between 1980 and 2003, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DKX by decision year
YearClearances
19801
20031

Applicants with the most clearances

Product code DKX
Applicants holding the most 510(k) clearances under product code DKX
ApplicantClearances
Hoffrel Instruments, Inc.1
Icn Biomedicals, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code