The following data is part of a premarket notification filed by Siemens Medical Solutions Diagnostics with the FDA for Advia Centaur Cyclosporine Assay And Calibrator.
| Device ID | K071455 |
| 510k Number | K071455 |
| Device Name: | ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR |
| Classification | Cyclosporine |
| Applicant | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Mary Seeger |
| Correspondent | Mary Seeger SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | MKW |
| CFR Regulation Number | 862.1235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-25 |
| Decision Date | 2008-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598765 | K071455 | 000 |
| 00630414598741 | K071455 | 000 |
| 00630414598734 | K071455 | 000 |
| 00630414598727 | K071455 | 000 |
| 00630414525549 | K071455 | 000 |
| 00630414524481 | K071455 | 000 |
| 00630414524474 | K071455 | 000 |
| 00630414524450 | K071455 | 000 |