The following data is part of a premarket notification filed by Cambridge Medical Technology with the FDA for T3 Uptake Radioimmunoassay Kit.
| Device ID | K855169 |
| 510k Number | K855169 |
| Device Name: | T3 UPTAKE RADIOIMMUNOASSAY KIT |
| Classification | Radioassay, Triiodothyronine Uptake |
| Applicant | CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica, MA 01865 |
| Contact | Sandra L Fan |
| Correspondent | Sandra L Fan CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica, MA 01865 |
| Product Code | KHQ |
| CFR Regulation Number | 862.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-26 |
| Decision Date | 1986-02-06 |