K103548 is an FDA 510(k) clearance for the ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491. This device is classified as a Calibrator, Secondary (Class II - Special Controls, product code JIT).
Submitted by Siemens Healthcare Diagnostics, Inc. (East Walpole, US). The FDA issued a Cleared decision on June 2, 2011, 181 days after receiving the submission on December 3, 2010.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K103548 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2010 |
| Decision Date | June 02, 2011 |
| Days to Decision | 181 days |
| Submission Type | Abbreviated |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |