The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage(r) D-dimer Calibration Verification Controls; Triage(r) D-dimer Controls.
| Device ID | K050799 |
| 510k Number | K050799 |
| Device Name: | TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS |
| Classification | Plasma, Coagulation Control |
| Applicant | BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Contact | Rachael S Williamson |
| Correspondent | Rachael S Williamson BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-30 |
| Decision Date | 2005-06-29 |
| Summary: | summary |