K163554 is an FDA 510(k) clearance for the hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test. This device is classified as a Reagent, Occult Blood (Class II - Special Controls, product code KHE).
Submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on January 17, 2017, 29 days after receiving the submission on December 19, 2016.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6550.
| 510(k) Number | K163554 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2016 |
| Decision Date | January 17, 2017 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | KHE - Reagent, Occult Blood |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6550 |