The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Vista Loci Ca 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator, Models: K6456 And Kc605.
| Device ID | K100344 |
| 510k Number | K100344 |
| Device Name: | DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 |
| Classification | System, Test, Immunological, Antigen, Tumor |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Rose Marinelli |
| Correspondent | Rose Marinelli SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | MOI |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-05 |
| Decision Date | 2011-04-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768028526 | K100344 | 000 |