The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage Protein C Controls And Calibration Verification Controls.
| Device ID | K062840 |
| 510k Number | K062840 |
| Device Name: | TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS |
| Classification | Plasma, Coagulation Control |
| Applicant | BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD San Diego, CA 92121 |
| Contact | Fil V Buenviaje |
| Correspondent | Fil V Buenviaje BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD 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 | 2006-09-22 |
| Decision Date | 2007-03-01 |
| Summary: | summary |