K171484 is an FDA 510(k) clearance for the hema-screen SPECIFIC Gold. 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 June 14, 2017, 23 days after receiving the submission on May 22, 2017.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6550.
| 510(k) Number | K171484 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2017 |
| Decision Date | June 14, 2017 |
| Days to Decision | 23 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 |