The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage D-dimer Test, Model 98100.
| Device ID | K042890 |
| 510k Number | K042890 |
| Device Name: | TRIAGE D-DIMER TEST, MODEL 98100 |
| Classification | Fibrin Split Products |
| Applicant | BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Contact | Jeffery R Dahlen |
| Correspondent | Jeffery R Dahlen BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Product Code | GHH |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-19 |
| Decision Date | 2004-11-29 |
| Summary: | summary |