The following data is part of a premarket notification filed by Syva Co. with the FDA for Syva Emit D.a.u. Cocaine Metabolite.
| Device ID | K914973 |
| 510k Number | K914973 |
| Device Name: | SYVA EMIT D.A.U. COCAINE METABOLITE |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Contact | Paul L Rogers |
| Correspondent | Paul L Rogers SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-06 |
| Decision Date | 1991-11-29 |