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 | K062203 |
| 510k Number | K062203 |
| Device Name: | TINA-QUANT D-DIMER TEST SYSTEM |
| Classification | Fibrin Split Products |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Theresa Ambrose Bush |
| Correspondent | Theresa Ambrose Bush ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | GHH |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-01 |
| Decision Date | 2007-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336133651 | K062203 | 000 |