K080812 is an FDA 510(k) clearance for the HEMOCCULT ICT. This device is classified as a Reagent, Occult Blood (Class II - Special Controls, product code KHE).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on June 25, 2008, 93 days after receiving the submission on March 24, 2008.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6550.
| 510(k) Number | K080812 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2008 |
| Decision Date | June 25, 2008 |
| Days to Decision | 93 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 |