The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit(r) Ii 9 Cannabinoid Negative Calibra/controls.
| Device ID | K904569 |
| 510k Number | K904569 |
| Device Name: | EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS |
| Classification | Calibrators, Drug Specific |
| 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 | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-09 |
| Decision Date | 1990-12-26 |