The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit D.a.u. Phencyclidine Assay.
| Device ID | K915728 |
| 510k Number | K915728 |
| Device Name: | EMIT D.A.U. PHENCYCLIDINE ASSAY |
| Classification | Enzyme Immunoassay, Phencyclidine |
| Applicant | SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Contact | Rogers, Jr. |
| Correspondent | Rogers, Jr. SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Product Code | LCM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-20 |
| Decision Date | 1992-01-27 |