The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Roche Diagnostics Calibrator For Automated Systems, Roche Diagnostics Calibrator Calibrator For Automated System.
| Device ID | K101456 |
| 510k Number | K101456 |
| Device Name: | ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Susan Hollandbeck |
| Correspondent | Susan Hollandbeck Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-26 |
| Decision Date | 2010-09-08 |
| Summary: | summary |