The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Centaur Ige Master Curve Material.
| Device ID | K143680 |
| 510k Number | K143680 |
| Device Name: | ADVIA Centaur IgE 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 | 2015-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414599403 | K143680 | 000 |
| 00630414126265 | K143680 | 000 |