The following data is part of a premarket notification filed by Roche Diagnostics Operations (rdo) with the FDA for Total Protein Urine/csf Gen.3.
| Device ID | K141925 |
| 510k Number | K141925 |
| Device Name: | TOTAL PROTEIN URINE/CSF GEN.3 |
| Classification | Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Patrick Stimart |
| Correspondent | Patrick Stimart Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | JIQ |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-16 |
| Decision Date | 2014-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121535 | K141925 | 000 |