The following data is part of a premarket notification filed by Serono Diagnostics, Inc. with the FDA for T3 Serozyme Enzymeimmunoassay Kit, Mag Solid Phase.
| Device ID | K880388 |
| 510k Number | K880388 |
| Device Name: | T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| 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 | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-28 |
| Decision Date | 1988-03-03 |