The following data is part of a premarket notification filed by Advandx, Inc. with the FDA for Meca Xpressfish.
| Device ID | K140619 |
| 510k Number | K140619 |
| Device Name: | MECA XPRESSFISH |
| Classification | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies |
| Applicant | ADVANDX, INC. 400 TradeCenter Suite 6990 Woburn, MA 01801 |
| Contact | Ron Eisenwinter |
| Correspondent | Ron Eisenwinter ADVANDX, INC. 400 TradeCenter Suite 6990 Woburn, MA 01801 |
| Product Code | MYI |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-11 |
| Decision Date | 2014-10-10 |
| Summary: | summary |