K100817 is an FDA 510(k) clearance for the BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST. This device is classified as a Reagent, Occult Blood (Class II - Special Controls, product code KHE).
Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on July 1, 2010, 104 days after receiving the submission on March 19, 2010.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6550.
| 510(k) Number | K100817 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2010 |
| Decision Date | July 01, 2010 |
| Days to Decision | 104 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 |