DLN — Hemagglutination, Cocaine Metabolites (Benzoylecgnonine) Class II
FDA product code DLN covers "Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)", a Class II medical device regulated under 21 CFR 862.3250. Submissions are reviewed by the Clinical Toxicology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DLN
- Device Class
- Class II
- Regulation Number
- 862.3250
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K950134 | E.I. Dupont De Nemours And Co | URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE | Mar 21, 1995 |
| K924113 | Roche Diagnostic Systems | ABUSCREEN ONLINE FOR COCAINE METABOLITE | Dec 28, 1992 |
| K792429 | Tecknam | HIM TEST COCAINE | Dec 7, 1979 |
| K760401 | J.T. Baker Chemical | COCAINE KIT, TOXI-PAK | Aug 26, 1976 |