The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Modification To Tina-quant D-dimer Test System.
| Device ID | K030740 |
| 510k Number | K030740 |
| Device Name: | MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM |
| Classification | Fibrin Split Products |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Sherri L Coenen |
| Correspondent | Sherri L Coenen ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | GHH |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-10 |
| Decision Date | 2003-04-01 |
| Summary: | summary |