K092283 is an FDA 510(k) clearance for the DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG. This device is classified as a Igg (gamma Chain Specific), Antigen, Antiserum, Control (Class II - Special Controls, product code DFZ).
Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on October 21, 2009, 84 days after receiving the submission on July 29, 2009.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K092283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2009 |
| Decision Date | October 21, 2009 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DFZ — Igg (gamma Chain Specific), Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |