The following data is part of a premarket notification filed by Icubate, Inc with the FDA for Ic-gpc Assay Tm For Use On The Ic-systemtm.
| Device ID | K163390 |
| 510k Number | K163390 |
| Device Name: | IC-GPC Assay TM For Use On The IC-SystemTM |
| Classification | Gram-positive Bacteria And Their 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 | PAM |
| CFR Regulation Number | 866.3365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-02 |
| Decision Date | 2017-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B769ICRADAA00000 | K163390 | 000 |
| B769ICPADAAA0000 | K163390 | 000 |
| B769ICCAAJA00000 | K163390 | 000 |