The following data is part of a premarket notification filed by Serono Diagnostics, Inc. with the FDA for T3 Uptake Serozyme Enzyme Immuno Kt/mag Solid Phas.
| Device ID | K883085 |
| 510k Number | K883085 |
| Device Name: | T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS |
| Classification | Radioassay, Triiodothyronine Uptake |
| 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 | KHQ |
| CFR Regulation Number | 862.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-22 |
| Decision Date | 1988-09-09 |