510(k) K181461
K181461 is an FDA 510(k) premarket notification submitted by Vitrolife Sweden AB for the device "Rapid-i Kit". The FDA issued a decision of Substantially Equivalent on January 4, 2019. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Vitrolife Sweden AB has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 2019
- Date Received
- June 4, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Labware, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6160
- Review Panel
- OB
- Submission Type