K103701 is an FDA 510(k) clearance for the ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS. This device is classified as a Calibrator, Multi-analyte Mixture (Class II - Special Controls, product code JIX).
Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on February 18, 2011, 60 days after receiving the submission on December 20, 2010.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K103701 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2010 |
| Decision Date | February 18, 2011 |
| Days to Decision | 60 days |
| Submission Type | Abbreviated |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JIX — Calibrator, Multi-analyte Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |