The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit Convenience Pack, Quinidine Assay/calibrators.
| Device ID | K904990 |
| 510k Number | K904990 |
| Device Name: | EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS |
| Classification | Enzyme Immunoassay, Quinidine |
| 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 | LBZ |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-06 |
| Decision Date | 1991-02-04 |