510(k) K973351
K973351 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "ELECSYS AFP". The FDA issued a decision of Substantially Equivalent on November 21, 1997. The device falls under product code LOJ (Kit, Test,Alpha-Fetoprotein For Testicular Cancer), a Class II device regulated under 21 CFR 866.6010. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 1997
- Date Received
- September 5, 1997
- 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