510(k) K100596
K100596 is an FDA 510(k) premarket notification submitted by Mid-Atlantic Diagnostics, Inc. for the device "CRYOPETTE". The FDA issued a decision of Substantially Equivalent on December 6, 2010. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Mid-Atlantic Diagnostics, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 2010
- Date Received
- March 2, 2010
- 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