The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage Bnp Calibration Verification Controls.
| Device ID | K000231 |
| 510k Number | K000231 |
| Device Name: | TRIAGE BNP CALIBRATION VERIFICATION CONTROLS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Contact | John F Bruni |
| Correspondent | John F Bruni BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-27 |
| Decision Date | 2000-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613337034 | K000231 | 000 |