The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur Calibarator 80 Model 10492491.
| Device ID | K103548 |
| 510k Number | K103548 |
| Device Name: | ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 |
| Classification | Calibrator, Secondary |
| Applicant | Siemens Healthcare Diagnostics Inc. 333 CONEY STREET East Walpole, MA 02032 |
| Contact | Sandra D White |
| Correspondent | Sandra D White Siemens Healthcare Diagnostics Inc. 333 CONEY STREET East Walpole, MA 02032 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-03 |
| Decision Date | 2011-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598246 | K103548 | 000 |
| 00630414580111 | K103548 | 000 |