510(k) K081709
K081709 is an FDA 510(k) premarket notification submitted by Olympus Life Science Research Europa GmbH (Europa) for the device "OLYMPUS AFP - ALPHA-FETOPROTEIN". The FDA issued a decision of Substantially Equivalent on March 16, 2009. The device falls under product code LOJ (Kit, Test,Alpha-Fetoprotein For Testicular Cancer), a Class II device regulated under 21 CFR 866.6010. Olympus Life Science Research Europa GmbH (Europa) has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2009
- Date Received
- June 17, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Test,Alpha-Fetoprotein For Testicular Cancer
- Device Class
- Class II
- Regulation Number
- 866.6010
- Review Panel
- IM
- Submission Type