510(k) K024337
K024337 is an FDA 510(k) premarket notification submitted by Bioshaf , Ltd. for the device "GENERAL SEMEN ANALYSIS (GSA) KIT". The FDA issued a decision of Substantially Equivalent on July 3, 2003. The device falls under product code POV (Semen Analysis Device), a Class II device regulated under 21 CFR 864.5220.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2003
- Date Received
- December 27, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Semen Analysis Device
- Device Class
- Class II
- Regulation Number
- 864.5220
- Review Panel
- HE
- Submission Type
Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH.