K143325 is an FDA 510(k) clearance for the OC-Light S FIT. This device is classified as a Reagent, Occult Blood (Class II - Special Controls, product code KHE).
Submitted by Eiken Chemical Co., Ltd. (Taito-Ku, JP). The FDA issued a Cleared decision on August 20, 2015, 273 days after receiving the submission on November 20, 2014.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6550.
| 510(k) Number | K143325 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2014 |
| Decision Date | August 20, 2015 |
| Days to Decision | 273 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 |