Emit ST Urine Methaqualone Assay
FDA 510(k) K840164 · Syva Co.
510(k) numberK840164
Submission
- Device name
- Emit ST Urine Methaqualone Assay
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- January 16, 1984
- Decision date
- March 22, 1984
- 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 |
|---|---|---|
| K011878 | Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators…DKJ · Traditional | 08/13/2001SE |
| K012257 | Emit II Plus Monoclonal Amphetamine/Methamphetamine Assay Model OSR9C229DKZ · Special | 08/03/2001SE |
| K011947 | Emit 2000 Valproic Acid Assay, Model OSR4G229ULLEG · Special | 07/02/2001SE |
| K011528 | Emit 2000 Phenobarbital Assay, Model OSR4D229DLZ · Special | 06/06/2001SE |
| K011347 | Emit 2000 Phenytoin Assay, Model 0SR4A229DIP · Special | 05/17/2001SE |
| K993981 | Syva Emit II Plus Propoxyphene Assay, Models 9G029UL/9G129ULJXN · Traditional | 02/01/2000SE |
| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional | 02/01/2000SE |
| K993988 | Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029ULDIO · Traditional | 01/27/2000SE |
| K993987 | Syva Emit II Plus Barbiturate Assay, Model 9D029UL/9D129ULKLT · Traditional | 01/27/2000SE |
| K993986 | Syva Emit II Plus Methaqualone Assay, Model 9Q029UL/9Q129ULKXS · Traditional | 01/27/2000SE |
Questions and answers
When was Emit ST Urine Methaqualone Assay cleared by the FDA?
Emit ST Urine Methaqualone Assay (K840164) received a 510(k) decision of Substantially Equivalent on March 22, 1984, 66 days after the submission was received.
What is the product code of K840164?
The FDA product code is KXS – Radioimmunoassay, Methaqualone, a Class II (moderate risk) device regulated under 21 CFR 862.3630.