TRIAGE BNP CALIBRATION VERIFICATION CONTROLS— 510(k) K000231

Substantially Equivalent

Biosite Incorporated

FDA 510(k) clearance K000231 for TRIAGE BNP CALIBRATION VERIFICATION CONTROLS, Substantially Equivalent on 2000-03-02. Applicant: Biosite Incorporated.

Clearance details

Applicant: Biosite Incorporated
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2000-01-27
Decision date: 2000-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.