510(k) K112413
K112413 is an FDA 510(k) premarket notification submitted by Research Instruments , Ltd. for the device "RI MSC (MIGRATION SEDIMENTATION CHAMBER)". The FDA issued a decision of Substantially Equivalent on July 13, 2012. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Research Instruments , Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 2012
- Date Received
- August 22, 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