K100344 is an FDA 510(k) clearance for the DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605. This device is classified as a System, Test, Immunological, Antigen, Tumor (Class II - Special Controls, product code MOI).
Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on April 18, 2011, 437 days after receiving the submission on February 5, 2010.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K100344 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2010 |
| Decision Date | April 18, 2011 |
| Days to Decision | 437 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | MOI — System, Test, Immunological, Antigen, Tumor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |