510(k) K981282
K981282 is an FDA 510(k) premarket notification submitted by Roche Diagnostics GmbH for the device "ELECSYS AFP". The FDA issued a decision of Substantially Equivalent on May 1, 1998. The device falls under product code LOJ (Kit, Test,Alpha-Fetoprotein For Testicular Cancer), a Class II device regulated under 21 CFR 866.6010. Roche Diagnostics GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 1998
- Date Received
- April 8, 1998
- 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