Modification to the Emit II Plus Methaqualone Assay, Model OSR9Q229
FDA 510(k) K011164 · Syva Co., Dade Behring, Inc.
510(k) numberK011164
Submission
- Device name
- Modification to the Emit II Plus Methaqualone Assay, Model OSR9Q229
- Applicant
- Syva Co., Dade Behring, Inc.
San Jose, CA, US - Received
- April 16, 2001
- Decision date
- May 10, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| 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 |
More from Syva Co.
| 510(k) | Device | Decision |
|---|---|---|
| K011920 | Emit 2000 Digoxin Assay, Model OSR4H229KXT · Special | 07/02/2001SE |
| K011620 | Emit 2000 N-Acetylprocainamide Assay, Model OSR4N229LAN · Special | 06/18/2001SE |
| K011605 | Emit 2000 Quinidine Assay, Model OSR4Q229LBZ · Special | 06/12/2001SE |
| K011300 | Emit II Plus Cannabinoid Assay, Model OSR9N229LDJ · Special | 05/17/2001SE |
| K011306 | Emit II Plus Benzodiazepine Assay, Model 0SR9F229JXM · Special | 05/16/2001SE |
| K011289 | Emit II Plus Opiate Assay, Model OSR9B229DJG · Special | 05/15/2001SE |
| K011161 | Modification to the Emit II Plus Phencyclidine Assay, Model OSR9J229LCM · Special | 05/15/2001SE |
| K011166 | Modification to Emit 2000 Theophylline Assay, Model Osr 4P229KLS · Special | 05/10/2001SE |
| K011163 | Modification to the Emit II Plus Propoxyphene Assay, Model OSR9G229JXN · Special | 05/10/2001SE |
| K011162 | Modification to the Emit II Plus Cocaine Metabolite AssayDIO · Special | 05/02/2001SE |
Questions and answers
When was Modification to the Emit II Plus Methaqualone Assay, Model OSR9Q229 cleared by the FDA?
Modification to the Emit II Plus Methaqualone Assay, Model OSR9Q229 (K011164) received a 510(k) decision of Substantially Equivalent on May 10, 2001, 24 days after the submission was received.
What is the product code of K011164?
The FDA product code is KXS – Radioimmunoassay, Methaqualone, a Class II (moderate risk) device regulated under 21 CFR 862.3630.