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 | March 21, 1995 |
| K924113 | roche diagnostic systems | ABUSCREEN ONLINE FOR COCAINE METABOLITE | December 28, 1992 |
| K792429 | tecknam | HIM TEST COCAINE | December 7, 1979 |
| K760401 | j.t. baker chemical | COCAINE KIT, TOXI-PAK | August 26, 1976 |