Radioimmunoassay, Cannabinoid(S)
FDA product code LAT · Class II (moderate risk) · 21 CFR 862.3870 · Clinical Toxicology
16510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011426 | Psychemedics Ria Cannabinoid AssayLAT · Traditional | Psychemedics Corp. | 05/03/2002SE |
| K961620 | Abiscreen Online for Cannabinoids - Es 50/100LAT · Traditional | Roche Diagnostic Systems, Inc. | 06/13/1996SE |
| K936135 | Sudormed Sweat Patch Specimen Container for Collection of Marijuana in PerspirationLAT · Traditional | Sudormed, Inc. | 06/10/1996SE |
| K914507 | Double Antibody Cannabionoids/Quail Deter in UrineLAT · Traditional | Diagnostic Products Corp. | 12/18/1991SE |
| K913414 | Abuscreen(R) Online(Tm) for THC(50/100)(100TEST KTLAT · Traditional | Roche Diagnostic Systems, Inc. | 09/25/1991SE |
| K913865 | Urine THC Direct Ria Kit (I-125)LAT · Traditional | Immunalysis Corporation | 09/18/1991SE |
| K912574 | Abuscreen Online for THC (50 and 100)LAT · Traditional | Roche Diagnostic Systems, Inc. | 08/12/1991SE |
| K904996 | Abuscreen Online TM for THCLAT · Traditional | Roche Diagnostic Systems, Inc. | 01/11/1991SE |
| K843534 | Oral Thc-Cannabinoids Direct Ria KitLAT · Traditional | Immunalysis Corporation | 10/30/1984SE |
| K833911 | Urine THC Cannabinoids Direct Ria KitLAT · Traditional | Immunalysis Corporation | 01/24/1984SE |
| K821965 | Oral Thc-Cannabinoids Direct Ria KitLAT · Traditional | Immunalysis Corporation | 07/20/1982SE |
| K820903 | Thc-Cannabinoids Direct Urine Ria KitLAT · Traditional | Immunalysis Corporation | 05/05/1982SE |
| K820391 | Abuscreen Radioimmunoassay for CannabiLAT · Traditional | Hoffmann-La Roche, Inc. | 03/08/1982SE |
| K800246 | Emit -D.A.U. Cannabinoid Urine AssayLAT · Traditional | Syva Co. | 02/26/1980SE |
| K791649 | Tetrahydrocannalbinol Direct Blood KitLAT · Traditional | Immunalysis Corporation | 10/11/1979SE |
| K781048 | THC Direct Ria KitLAT · Traditional | Immunalysis Corporation | 10/03/1978SE |