The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Centaur C-peptide (cps) Master Curve Material (mcm), Advia Centaur Insulin (iri) Master Curve Material (mcm).
| Device ID | K142864 |
| 510k Number | K142864 |
| Device Name: | ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM) |
| 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 | 2014-10-01 |
| Decision Date | 2014-10-29 |
| Summary: | summary |