510(k) K092116
K092116 is an FDA 510(k) premarket notification submitted by Medica Corp. for the device "EASYCELL CELL LOCATOR". The FDA issued a decision of Substantially Equivalent on May 12, 2010. The device falls under product code JOY (Device, Automated Cell-Locating), a Class II device regulated under 21 CFR 864.5260. Medica Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 2010
- Date Received
- July 14, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Automated Cell-Locating
- Device Class
- Class II
- Regulation Number
- 864.5260
- Review Panel
- HE
- Submission Type