K090236 is an FDA 510(k) clearance for the DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454. This device is classified as a Kit, Test,alpha-fetoprotein For Testicular Cancer (Class II - Special Controls, product code LOJ).
Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on April 27, 2009, 84 days after receiving the submission on February 2, 2009.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K090236 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2009 |
| Decision Date | April 27, 2009 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | LOJ — Kit, Test,alpha-fetoprotein For Testicular Cancer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |