The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Diagnostics Cardiac D-dimer Rapid Assay; Roche Diagnostics Cardiac D-dimer Controls.
| Device ID | K033491 |
| 510k Number | K033491 |
| Device Name: | ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46256 |
| Contact | Jennifer Tribbett |
| Correspondent | Jennifer Tribbett ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46256 |
| Product Code | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-04 |
| Decision Date | 2004-09-01 |
| Summary: | summary |