K121397 is an FDA 510(k) clearance for the OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT. This device is classified as a Reagent, Occult Blood (Class II - Special Controls, product code KHE).
Submitted by SEKISUI Diagnostics, LLC (San Diego, US). The FDA issued a Cleared decision on December 28, 2012, 233 days after receiving the submission on May 9, 2012.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6550.
| 510(k) Number | K121397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2012 |
| Decision Date | December 28, 2012 |
| Days to Decision | 233 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 |