K081299 is an FDA 510(k) clearance for the DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA. This device is classified as a Transferrin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDG).
Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on August 8, 2008, 92 days after receiving the submission on May 8, 2008.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5880.
| 510(k) Number | K081299 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2008 |
| Decision Date | August 08, 2008 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DDG — Transferrin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5880 |