The following data is part of a premarket notification filed by Advandx, Inc. with the FDA for Gram-negative Quickfish Bc.
| Device ID | K123418 |
| 510k Number | K123418 |
| Device Name: | GRAM-NEGATIVE QUICKFISH BC |
| Classification | Kit, Identification, Enterobacteriaceae |
| 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 | JSS |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-06 |
| Decision Date | 2013-07-21 |