ADVIA Centaur® Digoxin Assay
Enzyme Immunoassay, Digoxin
Siemens Healthcare Diagnostics, Inc.
The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Centaur® Digoxin Assay.
Pre-market Notification Details
| Device ID | K193397 |
| 510k Number | K193397 |
| Device Name: | ADVIA Centaur® Digoxin Assay |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Anoop Joy |
| Correspondent | Anoop Joy Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-06 |
| Decision Date | 2021-07-16 |
Trademark Results [ADVIA Centaur]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADVIA CENTAUR 75658644 2427460 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1999-03-11 |
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