KXS — Radioimmunoassay, Methaqualone Class II
FDA Device Classification
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 |