EASYCELL CELL LOCATOR
510(k)K092116HematologyJOY
MEDICA CORP. is listed for EASYCELL CELL LOCATOR (K092116). The FDA list gives May 12, 2010 as the date of the final decision. The lead panel is Hematology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is JOY. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K092116
- Date of final decision
- May 12, 2010
- Company on the FDA list
- MEDICA CORP.
- Lead panel
- Hematology
- Primary product code
- JOY
- openFDA device name for the code
- Device, Automated Cell-Locating
- Device class
- 2
- Regulation number
- 864.5260
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary