The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easycell Cell Locator.
| Device ID | K092116 |
| 510k Number | K092116 |
| Device Name: | EASYCELL CELL LOCATOR |
| Classification | Device, Automated Cell-locating |
| Applicant | MEDICA CORP. 163 CABOT STREET Beverly, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White MEDICA CORP. 163 CABOT STREET Beverly, MA 01915 |
| Product Code | JOY |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-14 |
| Decision Date | 2010-05-12 |
| Summary: | summary |