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

Thin Layer Chromatography, Morphine

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

DNK is the FDA product code for Thin Layer Chromatography, Morphine, a class II device type, regulated under 21 CFR 862.3640. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DNK
Device name
Thin Layer 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
4
Ingested recalls
0

Clearances, product code DNK

By decision year
4 clearances under product code DNK with a decision year between 1986 and 2015, 2015 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DNK by decision year
YearClearances
19861
19971
20152

Applicants with the most clearances

Product code DNK
Applicants holding the most 510(k) clearances under product code DNK
ApplicantClearances
Guangzhou Wondfo Biotech Co., Ltd.1
Medical Diagnostics, Ca.1
Nantong Egens Biotech Co., Ltd.1
Teco Diagnostics1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order