KXS — Radioimmunoassay, Methaqualone Class II
FDA product code KXS covers "Radioimmunoassay, Methaqualone", a Class II medical device regulated under 21 CFR 862.3630. 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
- KXS
- Device Class
- Class II
- Regulation Number
- 862.3630
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K011164 | syva co., dade behring | MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229 | May 10, 2001 |
| K993986 | syva | SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL | January 27, 2000 |
| K955676 | beckman instruments | SYNCHRON SYSTEMS METHAQUALONE REAGENT | March 4, 1996 |
| K945187 | roche diagnostic systems | ROCHE ABUSCREEN ONLINE FOR METHAQUALONE | April 5, 1995 |
| K940123 | diagnostic reagents | METHAQUALONE ENZYME IMMUNOASSAY | May 3, 1994 |
| K921013 | syva | SYVA EMIT II METHAQUALONE ASSAY | May 13, 1992 |
| K874272 | roche diagnostic systems | REVISED LABELING FOR METHAQUALONE TEST KIT | November 13, 1987 |
| K874199 | syva | REVISED LABELING FOR SYVA METHAQUALONE ASSAYS | October 28, 1987 |
| K873759 | diagnostic products | LABELING CHANGE COAT-A-COUNT METHAQUALONE | October 15, 1987 |
| K870935 | diagnostic products | COAT-A-COUNT METHAQUALONE TKMQ1 | March 19, 1987 |
| K843605 | syva | EMIT 700 METHAQUALONE ASSAY | October 5, 1984 |
| K840164 | syva | EMIT ST URINE METHAQUALONE ASSAY | March 22, 1984 |
| K830461 | hoffmann-la roche | ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE | March 24, 1983 |
| K822051 | syva | EMIT D.A.V. METHAQUALONE ASSAY | July 27, 1982 |
| K821768 | syva | EMIT ST URINE METHAGUALONE ASSAY | June 24, 1982 |
| K812987 | hoffmann-la roche | AGGLUTEX METHAQUALONE TEST KIT | December 22, 1981 |