The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Diagnostics Urisys 1100 Urine Analyzer.
| Device ID | K033548 |
| 510k Number | K033548 |
| Device Name: | ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER |
| Classification | Reagent, Occult Blood |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Jennifer Tribbett |
| Correspondent | Jennifer Tribbett ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-12 |
| Decision Date | 2003-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00075537253564 | K033548 | 000 |
| 00075537180075 | K033548 | 000 |
| 04015630946426 | K033548 | 000 |