The following data is part of a premarket notification filed by Syva Co. with the FDA for Vista Immunoassay System -- Modification.
| Device ID | K922139 |
| 510k Number | K922139 |
| Device Name: | VISTA IMMUNOASSAY SYSTEM -- MODIFICATION |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | SYVA CO. 3403 YERBA BUENA RD. San Jose, CA 95135 -1500 |
| Contact | Rogers, Jr. |
| Correspondent | Rogers, Jr. SYVA CO. 3403 YERBA BUENA RD. San Jose, CA 95135 -1500 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-16 |
| Decision Date | 1992-07-21 |