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 |