K051321 is an FDA 510(k) clearance for the INVIEW. This device is classified as a Assay, Glycosylated Hemoglobin (Class II - Special Controls, product code LCP).
Submitted by Metrika, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 13, 2005, 24 days after receiving the submission on May 20, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K051321 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2005 |
| Decision Date | June 13, 2005 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | LCP — Assay, Glycosylated Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7470 |