The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage Total 3 Controls And Calibration Verification Set.
| Device ID | K093032 |
| 510k Number | K093032 |
| Device Name: | TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD San Diego, CA 92121 |
| Contact | Mara Caler |
| Correspondent | Mara Caler BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD San Diego, CA 92121 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-29 |
| Decision Date | 2009-11-13 |
| Summary: | summary |