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])— 510(k) K200249
Substantially EquivalentKitazato Corporation
FDA 510(k) clearance K200249 for 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]), Substantially Equivalent on 2020-10-23. Applicant: Kitazato Corporation. Device class: 2.
Clearance details
- Applicant
- Kitazato Corporation
- Product code
- Code MQL
- Device class
- Class 2
- Regulation
- 21 CFR 884.6180
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fuji-Shi, JP
Recent devices under product code MQL
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