FDA product code DLN: Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)
DLN is the FDA product code for hemagglutination, cocaine metabolites (benzoylecgnonine). It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel. FDA has cleared 4 510(k) submissions under DLN, from 4 different applicants. The average 510(k) review took 58 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Hemagglutination, Cocaine Metabolites (Benzoylecgnonine) |
| Device class | Class II |
| Regulation | 21 CFR 862.3250 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DLN clearance
Top DLN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 1995-03-21 |
| Roche Diagnostic Systems, Inc. | 1 | 1992-12-28 |
| Tecknam, Inc. | 1 | 1979-12-07 |
| J.T. Baker Chemical Co. | 1 | 1976-08-26 |
Most recent DLN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950134 | E.I. Dupont DE Nemours & Co., Inc. | URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE | 1995-03-21 | 67 |
| K924113 | Roche Diagnostic Systems, Inc. | ABUSCREEN ONLINE FOR COCAINE METABOLITE | 1992-12-28 | 137 |
| K792429 | Tecknam, Inc. | HIM TEST COCAINE | 1979-12-07 | 9 |
| K760401 | J.T. Baker Chemical Co. | COCAINE KIT, TOXI-PAK | 1976-08-26 | 20 |
Recalls for DLN devices
openFDA lists no recalls for product code DLN.
Frequently asked questions
What is FDA product code DLN?
DLN is the FDA product code for hemagglutination, cocaine metabolites (benzoylecgnonine). It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel.
What device class is DLN?
Class II, regulation 21 CFR 862.3250. Typical premarket route: 510(k).
How long does a 510(k) take for product code DLN?
Across 4 cleared submissions the average was 58 days from receipt to decision (median 44).
Which companies have the most DLN clearances?
E.I. Dupont DE Nemours & Co., Inc. (1); Roche Diagnostic Systems, Inc. (1); Tecknam, Inc. (1); J.T. Baker Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DLN
- Run a recall and safety report across every DLN manufacturer
- Watch product code DLN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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