The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Tina-quant D-dimer Test System.
| Device ID | K011143 |
| 510k Number | K011143 |
| Device Name: | TINA-QUANT D-DIMER TEST SYSTEM |
| Classification | Fibrin Split Products |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Kay A Taylor |
| Correspondent | Kay A Taylor ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | GHH |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-13 |
| Decision Date | 2001-05-29 |