The following data is part of a premarket notification filed by Syva Co. with the FDA for Vista Thyroxine (t-4) Assay -- Modification.
| Device ID | K922433 |
| 510k Number | K922433 |
| Device Name: | VISTA THYROXINE (T-4) ASSAY -- MODIFICATION |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| 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 | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-16 |
| Decision Date | 1992-09-18 |