The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Vista Loci Ca 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6 Cal, Model#'s K6455, And Kc604.
| Device ID | K100321 |
| 510k Number | K100321 |
| Device Name: | DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604 |
| Classification | Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| 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 | LTK |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-04 |
| Decision Date | 2011-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768029325 | K100321 | 000 |
| 00842768028519 | K100321 | 000 |