The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Precinorm Proteins In Urine/csf (puc) And Precipath Puc.
| Device ID | K050026 |
| 510k Number | K050026 |
| Device Name: | PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Theresa M Ambrose |
| Correspondent | Theresa M Ambrose Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-06 |
| Decision Date | 2005-01-31 |
| Summary: | summary |