510(k) K153027
K153027 is an FDA 510(k) premarket notification submitted by Kitazato Biopharma Co., Ltd. for the device "Cryotop US". The FDA issued a decision of Substantially Equivalent on Mar 14, 2016. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Kitazato Biopharma Co., Ltd. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 14, 2016
- Date Received
- Oct 16, 2015
- 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
- 510(k)