SPERM CAPACITATION MEDIUM— 510(k) K861188
Substantially EquivalentIrvine Scientific
FDA 510(k) clearance K861188 for SPERM CAPACITATION MEDIUM, Substantially Equivalent on 1987-01-06. Applicant: Irvine Scientific. Device class: 2.
Clearance details
- Applicant
- Irvine Scientific
- Product code
- Code HDR
- Device class
- Class 2
- Regulation
- 21 CFR 884.5250
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Laguna Hills, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.