Submission Details
| 510(k) Number | K100321 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 04, 2010 |
| Decision Date | April 12, 2011 |
| Days to Decision | 432 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604
Apr 2011
Decision
432d
Days
Class 2
Risk
About This 510(k) Submission
K100321 is an FDA 510(k) clearance for the DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604, a Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (Class II — Special Controls, product code LTK), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on April 12, 2011, 432 days after receiving the submission on February 4, 2010. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.
Device Classification
| Product Code | LTK — Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.6010 |
Manufacturer
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