The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Total Protein Urine/csf Gen.3.
| Device ID | K071239 |
| 510k Number | K071239 |
| Device Name: | TOTAL PROTEIN URINE/CSF GEN.3 |
| Classification | Turbidimetric, Total Protein |
| Applicant | Roche Diagnostics 9155 HAGUE RD. PO BOX 50416 Indianapolis, IN 46250 |
| Contact | Corina Harper |
| Correspondent | Corina Harper Roche Diagnostics 9155 HAGUE RD. PO BOX 50416 Indianapolis, IN 46250 |
| Product Code | JGQ |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-03 |
| Decision Date | 2007-09-14 |
| Summary: | summary |