K041297 is an FDA 510(k) clearance for the POLYMEDCO OC LIGHT FOBT TEST. This device is classified as a Reagent, Occult Blood (Class II - Special Controls, product code KHE).
Submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on August 12, 2004, 90 days after receiving the submission on May 14, 2004.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6550.
| 510(k) Number | K041297 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2004 |
| Decision Date | August 12, 2004 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | KHE — Reagent, Occult Blood |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6550 |