K050487 is an FDA 510(k) clearance for the QUANTIA LA(A). This device is classified as a Lipoprotein, Low-density, Antigen, Antiserum, Control (Class II - Special Controls, product code DFC).
Submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on April 26, 2005, 60 days after receiving the submission on February 25, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5600.
| 510(k) Number | K050487 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2005 |
| Decision Date | April 26, 2005 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DFC — Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5600 |