SEMEN ANALYSIS KIT— 510(k) K915229
Substantially EquivalentHumagen Fertility Diagnostics, Inc.
FDA 510(k) clearance K915229 for SEMEN ANALYSIS KIT, Substantially Equivalent on 1994-08-30. Applicant: Humagen Fertility Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Humagen Fertility Diagnostics, Inc.
- Product code
- Code POV
- Device class
- Class 2
- Regulation
- 21 CFR 864.5220
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlottesville, VA, US
Recent devices under product code POV
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Data sourced from openFDA. This site is unofficial and independent of the FDA.