The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Modification To Roche Diagnostics Precinorm Proteins In Urine/csf (puc) And Precipath Proteins In Urine/csf (puc).
| Device ID | K041812 |
| 510k Number | K041812 |
| Device Name: | MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC) |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Theresa M Ambrose |
| Correspondent | Theresa M Ambrose ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-06 |
| Decision Date | 2004-07-27 |
| Summary: | summary |