KLN — Radioimmunoassay, Cocaine Metabolite Class II
FDA Device Classification
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 |