The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Dimension Vista Free Thyroxine Flex Reagent Cartridge, Ft4, Dimension Vista Thyroid Stimulating Hormone Flex Reagent.
| Device ID | K140859 |
| 510k Number | K140859 |
| Device Name: | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | Siemens Healthcare Diagnostics Inc. P.O. BOX 6101, M/S 514 Newark, DE 19714 |
| Contact | Frances A Dillon |
| Correspondent | Frances A Dillon Siemens Healthcare Diagnostics Inc. P.O. BOX 6101, M/S 514 Newark, DE 19714 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-03 |
| Decision Date | 2014-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768015731 | K140859 | 000 |
| 00842768015205 | K140859 | 000 |
| 00842768032417 | K140859 | 000 |