510(k) K032874
K032874 is an FDA 510(k) premarket notification submitted by Biocoat, Inc. for the device "HBA SPERM-HYALURONAN BINDING ASSAY". The FDA issued a decision of Substantially Equivalent on November 24, 2003. The device falls under product code POV (Semen Analysis Device), a Class II device regulated under 21 CFR 864.5220. Biocoat, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 2003
- Date Received
- September 15, 2003
- 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.