KLN — Radioimmunoassay, Cocaine Metabolite Class II
FDA product code KLN covers "Radioimmunoassay, Cocaine Metabolite", a Class II medical device regulated under 21 CFR 862.3250. Submissions are reviewed by the Clinical Toxicology panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KLN
- 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 |
|---|---|---|---|
| K010868 | psychemedics | PSYCHEMEDICS RIA COCAINE ASSAY | November 6, 2001 |
| K913867 | immunalysis corporation | URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) | September 19, 1991 |
| K913722 | roche diagnostic systems | ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE | September 10, 1991 |
| K912756 | roche diagnostic systems | ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE | July 26, 1991 |
| K910122 | v-tech | TARGET COCAINE METABOLITE-R | March 19, 1991 |
| K910123 | v-tech | TARGET COCAINE METABOLITE-V | March 19, 1991 |
| K910044 | diagnostic products | MILENIA COCAINE METABOLITE | February 13, 1991 |
| K905730 | roche diagnostic systems | ABUSCREEN ONTRAK FOR COCAINE (200NG/ML) | January 15, 1991 |
| K904995 | roche diagnostic systems | ABUSCREEN ONLINE TM FOR COCAINE METABOLITE | November 28, 1990 |
| K880674 | icn micromedic systems | MICROMEDIC CRACKPOT RIA KIT | October 6, 1988 |
| K871549 | immunalysis corporation | RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] | June 16, 1987 |
| K870740 | diagnostic products | COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5 | March 19, 1987 |
| K862218 | diagnostic products | DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT | June 27, 1986 |
| K830480 | hoffmann-la roche | ABUSCREEN RADIOIMMUNOASSAY-COCAINE META | March 24, 1983 |