510(k) K843699
K843699 is an FDA 510(k) premarket notification submitted by Bioself, Inc. for the device "BIOSELF TM 110". The FDA issued a decision of Substantially Equivalent on December 4, 1984. The device falls under product code LHD (Device, Fertility Diagnostic, Proceptive), a Class U device. Bioself, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1984
- Date Received
- September 20, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Fertility Diagnostic, Proceptive
- Device Class
- Class U
- Regulation Number
- Review Panel
- OB
- Submission Type