510(k) K140072
K140072 is an FDA 510(k) premarket notification submitted by Kitazato Biopharma Co., Ltd. for the device "CRYOTOP(R) SC". The FDA issued a decision of Substantially Equivalent on Apr 3, 2014. 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
- Apr 3, 2014
- Date Received
- Jan 13, 2014
- 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)