Agglutex Methaqualone Test Kit
FDA 510(k) K812987 · Hoffmann-La Roche, Inc.
510(k) numberK812987
Submission
- Device name
- Agglutex Methaqualone Test Kit
- Applicant
- Hoffmann-La Roche, Inc.
Mchenry, IL, US - Received
- October 26, 1981
- Decision date
- December 22, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KXS – Radioimmunoassay, Methaqualone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3630
- Specialty
- Clinical Toxicology
Other 510(k)s with product code KXS
| 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 |
More from Diagnostic Products Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K850727 | Bhcg-Roche EiaJHI · Traditional | 06/25/1985SE |
| K831694 | RenakCIB · Traditional | 07/19/1983SE |
| K830482 | Abuscreen Radioimmunoassay-AmphetamineDJP · Traditional | 03/24/1983SE |
| K830481 | Abuscreen Radioimmunoassay-PhencyclidineLCL · Traditional | 03/24/1983SE |
| K830480 | Abuscreen Radioimmunoassay-Cocaine MetaKLN · Traditional | 03/24/1983SE |
| K830462 | Abuscreen Radioummunoassay--UrineDOE · Traditional | 03/24/1983SE |
| K830461 | Abuscreen Radioummunoassay-MethaqualoneKXS · Traditional | 03/24/1983SE |
| K830460 | Abuscreen Radioimmunoassay for MorphineDOE · Traditional | 03/24/1983SE |
| K830479 | Abuscreen Radioimmunoassay-BarbiturateDKN · Traditional | 03/10/1983SE |
| K823580 | Cobas Reagent for Inorganic PhosphorusCEO · Traditional | 01/07/1983SE |
Questions and answers
When was Agglutex Methaqualone Test Kit cleared by the FDA?
Agglutex Methaqualone Test Kit (K812987) received a 510(k) decision of Substantially Equivalent on December 22, 1981, 57 days after the submission was received.
What is the product code of K812987?
The FDA product code is KXS – Radioimmunoassay, Methaqualone, a Class II (moderate risk) device regulated under 21 CFR 862.3630.