Roche Abuscreen Online for Methaqualone
FDA 510(k) K945187 · Roche Diagnostic Systems, Inc.
510(k) numberK945187
Submission
- Device name
- Roche Abuscreen Online for Methaqualone
- Applicant
- Roche Diagnostic Systems, Inc.
Branchburg, NJ, US - Received
- October 24, 1994
- Decision date
- April 5, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
More from Syva Co.
| 510(k) | Device | Decision |
|---|---|---|
| K983698 | Modification to Abuscreen Online BarbituratesDIS · Traditional | 05/03/1999SE |
| K983702 | Modification to Abuscreen Online for BenzoidiazepinesJXM · Traditional | 02/11/1999SE |
| K983704 | Modification to Abuscreen Online for PhencyclidineJCM · Traditional | 02/10/1999SE |
| K983556 | Abuscreen Online Benz 300 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983555 | Abuscreen Online Benz 200 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983703 | Modification to Abuscreen Online for MethadoneDJR · Special | 12/11/1998SE |
| K983701 | Modification to Abuscreen Online for CannabinoidsLDJ · Special | 12/11/1998SE |
| K983700 | Modification to Abuscreen Online for PropoxypheneJXN · Special | 12/11/1998SE |
| K983699 | Modification to Abuscreen Online for AmphetaminesDKZ · Special | 12/11/1998SE |
| K983697 | Modification to Abuscreen Online Cocaine MetaboliteDIO · Special | 12/11/1998SE |
Questions and answers
When was Roche Abuscreen Online for Methaqualone cleared by the FDA?
Roche Abuscreen Online for Methaqualone (K945187) received a 510(k) decision of Substantially Equivalent on April 5, 1995, 163 days after the submission was received.
What is the product code of K945187?
The FDA product code is KXS – Radioimmunoassay, Methaqualone, a Class II (moderate risk) device regulated under 21 CFR 862.3630.