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

Reagents, Test, Tetrahydrocannabinol

21 CFR 862.3870 / Clinical Toxicology
FDA source (opens on fda.gov)

DKE is the FDA product code for Reagents, Test, Tetrahydrocannabinol, a class II device type, regulated under 21 CFR 862.3870. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DKE
Device name
Reagents, Test, Tetrahydrocannabinol
Regulation
21 CFR 862.3870
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
12
Ingested recalls
0

Clearances, product code DKE

By decision year
12 clearances under product code DKE with a decision year between 1980 and 2000, 1999 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DKE by decision year
YearClearances
19801
19831
19841
19881
19901
19982
19993
20002

Applicants with the most clearances

Product code DKE
Applicants holding the most 510(k) clearances under product code DKE
ApplicantClearances
Princeton BioMeditech Corp.4
Marion Laboratories, Inc.2
MEDTOX Diagnostics, Inc.2
Alfa Scientific Designs, Inc.1
Biochemical Diagnostic, Inc.1
California Medical Developments, Inc.1
Toxi-Lab, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code