MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
FDA 510(k) clearance K011164 · decided 2001-05-10
Clearance details
- K-number
- K011164
- Device name
- MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
- Applicant
- Syva Co., Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-16
- Decision date
- 2001-05-10
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- KXS
- Device class
- 2
- Regulation number
- 862.3630
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL (K993986) | Syva Co. | 2000-01-27 |
| SYNCHRON SYSTEMS METHAQUALONE REAGENT (K955676) | Beckman Instruments, Inc. | 1996-03-04 |
| ROCHE ABUSCREEN ONLINE FOR METHAQUALONE (K945187) | Roche Diagnostic Systems, Inc. | 1995-04-05 |
| METHAQUALONE ENZYME IMMUNOASSAY (K940123) | Diagnostic Reagents, Inc. | 1994-05-03 |
| SYVA EMIT II METHAQUALONE ASSAY (K921013) | Syva Co. | 1992-05-13 |
| REVISED LABELING FOR METHAQUALONE TEST KIT (K874272) | Roche Diagnostic Systems, Inc. | 1987-11-13 |
| REVISED LABELING FOR SYVA METHAQUALONE ASSAYS (K874199) | Syva Co. | 1987-10-28 |
| LABELING CHANGE COAT-A-COUNT METHAQUALONE (K873759) | Diagnostic Products Corp. | 1987-10-15 |
| COAT-A-COUNT METHAQUALONE TKMQ1 (K870935) | Diagnostic Products Corp. | 1987-03-19 |
| EMIT 700 METHAQUALONE ASSAY (K843605) | Syva Co. | 1984-10-05 |
| EMIT ST URINE METHAQUALONE ASSAY (K840164) | Syva Co. | 1984-03-22 |
| ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE (K830461) | Hoffmann-La Roche, Inc. | 1983-03-24 |
Recalls involving this device
No recalls on record reference this clearance.