K163465 is an FDA 510(k) clearance for the hemochroma PLUS System. This device is classified as a System, Hemoglobin, Automated (Class II - Special Controls, product code GKR).
Submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on September 8, 2017, 270 days after receiving the submission on December 12, 2016.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5620.
| 510(k) Number | K163465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2016 |
| Decision Date | September 08, 2017 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKR - System, Hemoglobin, Automated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5620 |