The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit 700 Methaqualone Assay.
| Device ID | K843605 |
| 510k Number | K843605 |
| Device Name: | EMIT 700 METHAQUALONE ASSAY |
| Classification | Radioimmunoassay, Methaqualone |
| Applicant | SYVA CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KXS |
| CFR Regulation Number | 862.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-13 |
| Decision Date | 1984-10-05 |