K041764 is an FDA 510(k) clearance for the THE VITROS 5,1 FS CHEMISTRY SYSTEM. This device is classified as a Assay, Glycosylated Hemoglobin (Class II - Special Controls, product code LCP).
Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on September 9, 2004, 71 days after receiving the submission on June 30, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K041764 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2004 |
| Decision Date | September 09, 2004 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LCP — Assay, Glycosylated Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7470 |