The following data is part of a premarket notification filed by Syva Co. with the FDA for Syva Emit Ii Methaqualone Assay.
| Device ID | K921013 |
| 510k Number | K921013 |
| Device Name: | SYVA EMIT II METHAQUALONE ASSAY |
| Classification | Radioimmunoassay, Methaqualone |
| Applicant | SYVA CO. 3403 YERBA BUENA RD. San Jose, CA 95135 -1500 |
| Contact | Roger, Jr. |
| Correspondent | Roger, Jr. SYVA CO. 3403 YERBA BUENA RD. San Jose, CA 95135 -1500 |
| Product Code | KXS |
| CFR Regulation Number | 862.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-03 |
| Decision Date | 1992-05-13 |