510(k) K112695
K112695 is an FDA 510(k) premarket notification submitted by Kitazato Biopharma Co;Ltd for the device "CRYOTOP". The FDA issued a decision of Substantially Equivalent on Dec 12, 2012. 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
- Dec 12, 2012
- Date Received
- Sep 15, 2011
- 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)