510(k) K915229
K915229 is an FDA 510(k) premarket notification submitted by Humagen Fertility Diagnostics, Inc. for the device "SEMEN ANALYSIS KIT". The FDA issued a decision of Substantially Equivalent on August 30, 1994. The device falls under product code POV (Semen Analysis Device), a Class II device regulated under 21 CFR 864.5220. Humagen Fertility Diagnostics, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 1994
- Date Received
- November 20, 1991
- 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.