510(k) K122982
K122982 is an FDA 510(k) premarket notification submitted by Biotech, Inc. for the device "CRYOLOCK". The FDA issued a decision of Substantially Equivalent on Jan 9, 2014. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 9, 2014
- Date Received
- Sep 26, 2012
- 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)