Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])
FDA 510(k) clearance K200249 · decided 2020-10-23
Clearance details
- K-number
- K200249
- Device name
- Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])
- Applicant
- Kitazato Corporation
- Decision
- Substantially Equivalent
- Date received
- 2020-02-03
- Decision date
- 2020-10-23
- Days to decision
- 263 days
- Clearance type
- Traditional
- Product code
- MQL
- Device class
- 2
- Regulation number
- 884.6180
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Fuji-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.