K173212 is an FDA 510(k) clearance for the Instant-view-PLUS immunochemical Fecal Occult Blood Test. This device is classified as a Reagent, Occult Blood (Class II - Special Controls, product code KHE).
Submitted by Alfa Scientific Designs, Inc. (Powat, US). The FDA issued a Cleared decision on February 15, 2018, 136 days after receiving the submission on October 2, 2017.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6550.
| 510(k) Number | K173212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2017 |
| Decision Date | February 15, 2018 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| 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 |