The following data is part of a premarket notification filed by Syva Co., Dade Behring, Inc. with the FDA for Syva Emit 2000 Thyroxine Assay, Calibrators.
| Device ID | K000600 |
| 510k Number | K000600 |
| Device Name: | SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Applicant | SYVA CO., DADE BEHRING, INC. P.O. BOX 49013 3403 YERBA BUENA ROAD San Jose, CA 95161 -9013 |
| Contact | Paul L Rogers |
| Correspondent | Paul L Rogers SYVA CO., DADE BEHRING, INC. P.O. BOX 49013 3403 YERBA BUENA ROAD San Jose, CA 95161 -9013 |
| Product Code | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-23 |
| Decision Date | 2000-03-27 |