510(k) K080094
K080094 is an FDA 510(k) premarket notification submitted by Olympus Life Science Research Europa GmbH (Europa) for the device "OLYMPUS TOTAL BHCG TEST SYSTEN". The FDA issued a decision of Substantially Equivalent on September 3, 2008. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. 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
- September 3, 2008
- Date Received
- January 14, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Human Chorionic Gonadotropin
- Device Class
- Class II
- Regulation Number
- 862.1155
- Review Panel
- CH
- Submission Type