The following data is part of a premarket notification filed by Advandx, Inc. with the FDA for Enterococcus Quickfish Bc.
| Device ID | K121991 |
| 510k Number | K121991 |
| Device Name: | ENTEROCOCCUS QUICKFISH BC |
| Classification | Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis |
| Applicant | ADVANDX, INC. 400 TRADECENTER SUITE 6990 Woburn, MA 01801 |
| Contact | Benjamin S Crystal |
| Correspondent | Benjamin S Crystal ADVANDX, INC. 400 TRADECENTER SUITE 6990 Woburn, MA 01801 |
| Product Code | OAH |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-06 |
| Decision Date | 2013-01-07 |