Rapid-i Kit— 510(k) K181461
Substantially EquivalentVitrolife Sweden AB
FDA 510(k) clearance K181461 for Rapid-i Kit, Substantially Equivalent on 2019-01-04. Applicant: Vitrolife Sweden AB. Device class: 2.
Clearance details
- Applicant
- Vitrolife Sweden AB
- Product code
- Product code MQK
- Device class
- Class 2
- Regulation
- 21 CFR 884.6160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Västra Frölunda, SE
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