The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage Total Controls 5, Triage Total Calibration Verification 5.
| Device ID | K072892 |
| 510k Number | K072892 |
| Device Name: | TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-10 |
| Decision Date | 2007-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613337126 | K072892 | 000 |
| 30014613337119 | K072892 | 000 |
| 30014613337102 | K072892 | 000 |