The following data is part of a premarket notification filed by Olympus Life Science Research Europa Gmbh (europa) with the FDA for Olympus Afp - Alpha-fetoprotein.
| Device ID | K081709 |
| 510k Number | K081709 |
| Device Name: | OLYMPUS AFP - ALPHA-FETOPROTEIN |
| Classification | Kit, Test,alpha-fetoprotein For Testicular Cancer |
| Applicant | OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) LISMEEHAN O'callaghans Mills, Co. Clare, IE |
| Contact | Stephanie G Donnelly |
| Correspondent | Stephanie G Donnelly OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) LISMEEHAN O'callaghans Mills, Co. Clare, IE |
| Product Code | LOJ |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-17 |
| Decision Date | 2009-03-16 |