K050596 is an FDA 510(k) clearance for the QUANTIA A1-AT. This device is classified as a Alpha-1-antitrypsin, Antigen, Antiserum, Control (Class II - Special Controls, product code DEM).
Submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on May 13, 2005, 66 days after receiving the submission on March 8, 2005.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5130.
| 510(k) Number | K050596 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2005 |
| Decision Date | May 13, 2005 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DEM — Alpha-1-antitrypsin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5130 |