The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Advia Chemistry Drug Calibrator I Model 10376770.
| Device ID | K093732 |
| 510k Number | K093732 |
| Device Name: | ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770 |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Kira Gordon |
| Correspondent | Kira Gordon SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-04 |
| Decision Date | 2010-03-22 |
| Summary: | summary |