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

Free Radical Assay, Cocaine

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

DIR is the FDA product code for Free Radical Assay, Cocaine, a class II device type, regulated under 21 CFR 862.3250. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
DIR
Device name
Free Radical Assay, 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
1
Ingested recalls
0

Clearances, product code DIR

By decision year
1 clearance under product code DIR with a decision year between 1986 and 1986, 1986 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DIR by decision year
YearClearances
19861

Applicants with the most clearances

Product code DIR
Applicants holding the most 510(k) clearances under product code DIR
ApplicantClearances
E.I. Dupont de Nemours & Co., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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