510(k) K011164
- Device
- MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
- Applicant
- SYVA CO., DADE BEHRING, INC.
- 510(k) number
- K011164
- Product code
- KXS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-05-10
- Date received
- 2001-04-16
- Regulation
- 862.3630
- Classification name
- Radioimmunoassay, Methaqualone
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CYNTHIA ARREDONDO
- Address
- 3403 Yerba Buena Rd. San Jose CA US 95135 95135
FDA Registration Numbers#
- 3005360469
- 9610529
- 3010939897
- 2517506
- 2050010
- 9610126
- 2050012
- 3006198300
- 3003795116
Source Documents#
Other 510(k) Records For Product Code KXS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K993986 | SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL | Syva Co. | 2000-01-27 |
| K955676 | SYNCHRON SYSTEMS METHAQUALONE REAGENT | Beckman Instruments, Inc. | 1996-03-04 |
| K945187 | ROCHE ABUSCREEN ONLINE FOR METHAQUALONE | Roche Diagnostic Systems, Inc. | 1995-04-05 |
| K940123 | METHAQUALONE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1994-05-03 |
| K921013 | SYVA EMIT II METHAQUALONE ASSAY | Syva Co. | 1992-05-13 |
| K874272 | REVISED LABELING FOR METHAQUALONE TEST KIT | Roche Diagnostic Systems, Inc. | 1987-11-13 |
| K874199 | REVISED LABELING FOR SYVA METHAQUALONE ASSAYS | Syva Co. | 1987-10-28 |
| K873759 | LABELING CHANGE COAT-A-COUNT METHAQUALONE | Diagnostic Products Corp. | 1987-10-15 |
| K870935 | COAT-A-COUNT METHAQUALONE TKMQ1 | Diagnostic Products Corp. | 1987-03-19 |
| K843605 | EMIT 700 METHAQUALONE ASSAY | Syva Co. | 1984-10-05 |
| K840164 | EMIT ST URINE METHAQUALONE ASSAY | Syva Co. | 1984-03-22 |
| K830461 | ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE | Hoffmann-La Roche, Inc. | 1983-03-24 |
| K822051 | EMIT D.A.V. METHAQUALONE ASSAY | Syva Co. | 1982-07-27 |
| K821768 | EMIT ST URINE METHAGUALONE ASSAY | Syva Co. | 1982-06-24 |
| K812987 | AGGLUTEX METHAQUALONE TEST KIT | Hoffmann-La Roche, Inc. | 1981-12-22 |
Legacy Summary#
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FDA Review#
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