The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Dimension Vista Loci Total Testosterone Flex Reagent Cartridge, Dimension Vista Testosterone Calibrator.
| Device ID | K151529 |
| 510k Number | K151529 |
| Device Name: | Dimension Vista LOCI Total Testosterone Flex Reagent Cartridge, Dimension Vista Testosterone Calibrator |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC. 500 GBC DR. P.O. BOX 6101 M/S 514 Newark, DE 19714 |
| Contact | Julie Warren |
| Correspondent | Julie Warren SIEMENS HEALTHCARE DIAGNOSTICS, INC. 500 GBC DR. P.O. BOX 6101 M/S 514 Newark, DE 19714 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-08 |
| Decision Date | 2016-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414948775 | K151529 | 000 |
| 00842768026485 | K151529 | 000 |