The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur Tni-ultra Master Curve Material (mcm), Advia Centaur Digoxin Master Curve Material (mcm).
| Device ID | K140267 |
| 510k Number | K140267 |
| Device Name: | ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM) |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown, NY 10591 -5097 |
| Contact | Fatima Pacheco |
| Correspondent | Fatima Pacheco Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown, NY 10591 -5097 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-03 |
| Decision Date | 2014-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414515892 | K140267 | 000 |
| 00630414126296 | K140267 | 000 |
| 00630414600116 | K140267 | 000 |
| 00630414598833 | K140267 | 000 |