The following data is part of a premarket notification filed by Icubate, Inc. with the FDA for Ic-gn Ic-cassette For Use On The Ic-system.
| Device ID | K190341 |
| 510k Number | K190341 |
| Device Name: | IC-GN IC-Cassette For Use On The IC-System |
| Classification | Gram-negative Bacteria And Associated Resistance Markers |
| Applicant | iCubate, Inc. 601 Genome Way Huntsville, AL 35806 |
| Contact | Carter Wells |
| Correspondent | Fran White MDC Associates, LLC 180 Cabot Street Beverly, MA 01915 |
| Product Code | PEN |
| CFR Regulation Number | 866.3365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-14 |
| Decision Date | 2019-06-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B769ICCAAQA00000 | K190341 | 000 |