Radioimmunoassay, Methaqualone
FDA product code KXS · Class II (moderate risk) · 21 CFR 862.3630 · Clinical Toxicology
16510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011164 | Modification to the Emit II Plus Methaqualone Assay, Model OSR9Q229KXS · Special | Syva Co., Dade Behring, Inc. | 05/10/2001SE |
| K993986 | Syva Emit II Plus Methaqualone Assay, Model 9Q029UL/9Q129ULKXS · Traditional | Syva Co. | 01/27/2000SE |
| K955676 | Synchron Systems Methaqualone ReagentKXS · Traditional | Beckman Instruments, Inc. | 03/04/1996SE |
| K945187 | Roche Abuscreen Online for MethaqualoneKXS · Traditional | Roche Diagnostic Systems, Inc. | 04/05/1995SE |
| K940123 | Methaqualone Enzyme ImmunoassayKXS · Traditional | Diagnostic Reagents, Inc. | 05/03/1994SE |
| K921013 | Syva Emit II Methaqualone AssayKXS · Traditional | Syva Co. | 05/13/1992SE |
| K874272 | Revised Labeling for Methaqualone Test KitKXS · Traditional | Roche Diagnostic Systems, Inc. | 11/13/1987SE |
| K874199 | Revised Labeling for Syva Methaqualone AssaysKXS · Traditional | Syva Co. | 10/28/1987SE |
| K873759 | Labeling Change Coat-A-Count MethaqualoneKXS · Traditional | Diagnostic Products Corp. | 10/15/1987SE |
| K870935 | Coat-A-Count Methaqualone TKMQ1KXS · Traditional | Diagnostic Products Corp. | 03/19/1987SE |
| K843605 | Emit 700 Methaqualone AssayKXS · Traditional | Syva Co. | 10/05/1984SE |
| K840164 | Emit ST Urine Methaqualone AssayKXS · Traditional | Syva Co. | 03/22/1984SE |
| K830461 | Abuscreen Radioummunoassay-MethaqualoneKXS · Traditional | Hoffmann-La Roche, Inc. | 03/24/1983SE |
| K822051 | Emit D.A.V. Methaqualone AssayKXS · Traditional | Syva Co. | 07/27/1982SE |
| K821768 | Emit ST Urine Methagualone AssayKXS · Traditional | Syva Co. | 06/24/1982SE |
| K812987 | Agglutex Methaqualone Test KitKXS · Traditional | Hoffmann-La Roche, Inc. | 12/22/1981SE |