510(k) K052457
K052457 is an FDA 510(k) premarket notification submitted by Biocoat, Inc. for the device "PICSI SPERM SELECTION DEVICE". The FDA issued a decision of Substantially Equivalent on April 13, 2006. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Biocoat, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 2006
- Date Received
- September 7, 2005
- 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