The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit 2000 Quindine Assay Quididine Calibrators.
| Device ID | K922913 |
| 510k Number | K922913 |
| Device Name: | EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS |
| Classification | Enzyme Immunoassay, Quinidine |
| Applicant | SYVA CO. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Contact | Rogers, Jr. |
| Correspondent | Rogers, Jr. SYVA CO. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Product Code | LBZ |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-17 |
| Decision Date | 1992-08-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768001055 | K922913 | 000 |
| 00842768001048 | K922913 | 000 |