K071466 is an FDA 510(k) clearance for the DCA VANTAGE, MODEL 5075. This device is classified as a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP).
Submitted by Siemens Medical Solutions Diagnostics (Norowood, US). The FDA issued a Cleared decision on October 9, 2007, 133 days after receiving the submission on May 29, 2007.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K071466 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2007 |
| Decision Date | October 09, 2007 |
| Days to Decision | 133 days |
| Submission Type | Special |
| 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 |