The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche/hitachi Urinary/csf Protein With Model(s) Cat #11877801.
| Device ID | K072638 |
| 510k Number | K072638 |
| Device Name: | ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 |
| Classification | Turbidimetric, Total Protein |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Kerwin L Kaufman |
| Correspondent | Kerwin L Kaufman ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. 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 | 2007-09-18 |
| Decision Date | 2007-10-19 |
| Summary: | summary |