RAPID-I KIT
FDA 510(k) clearance K140207 · decided 2014-12-18
Clearance details
- K-number
- K140207
- Device name
- RAPID-I KIT
- Applicant
- Vitrolife Sweden AB
- Decision
- Substantially Equivalent
- Date received
- 2014-01-28
- Decision date
- 2014-12-18
- Days to decision
- 324 days
- Clearance type
- Traditional
- Product code
- MQK
- Device class
- 2
- Regulation number
- 884.6160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.