The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Advia Centaur Insulin (iri) Master Curve Material (mcm), Advia Centaur (iri) Calibrator.
| Device ID | K162538 |
| 510k Number | K162538 |
| Device Name: | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator |
| Classification | Calibrator, Secondary |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 333 CONEY STREET E. Walpole, MA 02032 |
| Contact | Susan Ferrin |
| Correspondent | Susan Ferrin SIEMENS HEALTHCARE DIAGNOSTICS 333 CONEY STREET E. Walpole, MA 02032 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-12 |
| Decision Date | 2016-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414600451 | K162538 | 000 |
| 00630414600482 | K162538 | 000 |