LAT — Radioimmunoassay, Cannabinoid(S) Class II
FDA product code LAT covers "Radioimmunoassay, Cannabinoid(S)", a Class II medical device regulated under 21 CFR 862.3870. Submissions are reviewed by the Clinical Toxicology panel. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LAT
- Device Class
- Class II
- Regulation Number
- 862.3870
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K011426 | psychemedics | PSYCHEMEDICS RIA CANNABINOID ASSAY | May 3, 2002 |
| K961620 | roche diagnostic systems | ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 | June 13, 1996 |
| K936135 | sudormed | SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRAT | June 10, 1996 |
| K914507 | diagnostic products | DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE | December 18, 1991 |
| K913414 | roche diagnostic systems | ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT | September 25, 1991 |
| K913865 | immunalysis corporation | URINE THC DIRECT RIA KIT (I-125) | September 18, 1991 |
| K912574 | roche diagnostic systems | ABUSCREEN ONLINE FOR THC (50 AND 100) | August 12, 1991 |
| K904996 | roche diagnostic systems | ABUSCREEN ONLINE TM FOR THC | January 11, 1991 |
| K843534 | immunalysis corporation | ORAL THC-CANNABINOIDS DIRECT RIA KIT | October 30, 1984 |
| K833911 | immunalysis corporation | URINE THC CANNABINOIDS DIRECT RIA KIT | January 24, 1984 |
| K821965 | immunalysis corporation | ORAL THC-CANNABINOIDS DIRECT RIA KIT | July 20, 1982 |
| K820903 | immunalysis corporation | THC-CANNABINOIDS DIRECT URINE RIA KIT | May 5, 1982 |
| K820391 | hoffmann-la roche | ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI | March 8, 1982 |
| K800246 | syva | EMIT -D.A.U. CANNABINOID URINE ASSAY | February 26, 1980 |
| K791649 | immunalysis corporation | TETRAHYDROCANNALBINOL DIRECT BLOOD KIT | October 11, 1979 |
| K781048 | immunalysis corporation | THC DIRECT RIA KIT | October 3, 1978 |