The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Advia Centaur Cyclosporine Master Curve Material.
| Device ID | K092993 |
| 510k Number | K092993 |
| Device Name: | ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Clare Santulli |
| Correspondent | Clare Santulli SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-28 |
| Decision Date | 2009-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598758 | K092993 | 000 |
| 00630414523798 | K092993 | 000 |