The following data is part of a premarket notification filed by Olympus Life & Material Science Europa Gmbh (irish with the FDA for Olympus Ft4-free Thyroxine, Olympus T4- Total Thyroxine, Model# Osr210102, Osr210104.
| Device ID | K070708 |
| 510k Number | K070708 |
| Device Name: | OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH LISMEEHAN, O'CALLAGHANS MILLS Co. Clare, IE |
| Contact | Stephanie G Schwartz |
| Correspondent | Stephanie G Schwartz OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH LISMEEHAN, O'CALLAGHANS MILLS Co. Clare, IE |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-14 |
| Decision Date | 2007-08-21 |