The following data is part of a premarket notification filed by Serono Diagnostics, Inc. with the FDA for T4 Serozyme Enzymeimmunoassay Kit/mag. Solid Phase.
| Device ID | K874866 |
| 510k Number | K874866 |
| Device Name: | T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Applicant | SERONO DIAGNOSTICS, INC. 100 LONGWATER CIRCLE Norwell, MA 02061 |
| Contact | Philip M Fantasia |
| Correspondent | Philip M Fantasia SERONO DIAGNOSTICS, INC. 100 LONGWATER CIRCLE Norwell, MA 02061 |
| Product Code | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-27 |
| Decision Date | 1988-02-11 |