The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Centaur Follicle Stimulating Hormone (fsh) Master Curve Material, Advia Centaur Ft4 Master Curve Material, Advia Centaur T4 Master Curve Material, Advia Centaur T3 Master Curve Material.
| Device ID | K143687 |
| 510k Number | K143687 |
| Device Name: | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVENUE Tarrytown, NY 10591 |
| Contact | Fatima Pacheco |
| Correspondent | Fatima Pacheco SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVENUE Tarrytown, NY 10591 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-24 |
| Decision Date | 2015-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414603094 | K143687 | 000 |
| 00630414603063 | K143687 | 000 |
| 00630414600000 | K143687 | 000 |
| 00630414126234 | K143687 | 000 |