510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DLNClass II

Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)

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

DLN is the FDA product code for Hemagglutination, Cocaine Metabolites (Benzoylecgnonine), a class II device type, regulated under 21 CFR 862.3250. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DLN
Device name
Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)
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
4
Ingested recalls
0

Clearances, product code DLN

By decision year
4 clearances under product code DLN with a decision year between 1976 and 1995, 1976 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DLN by decision year
YearClearances
19761
19791
19921
19951

Applicants with the most clearances

Product code DLN
Applicants holding the most 510(k) clearances under product code DLN
ApplicantClearances
E.I. Dupont de Nemours & Co., Inc.1
J.T. Baker Chemical Co.1
Roche Diagnostic Systems, Inc.1
Tecknam, 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 DLN.