TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS— 510(k) K000230

Substantially Equivalent

Biosite Incorporated

FDA 510(k) clearance K000230 for TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS, Substantially Equivalent on 2000-02-29. Applicant: Biosite Incorporated.

Clearance details

Applicant
Biosite Incorporated
Product code
Code JJX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JJX

product code JJX
Other
2
Total
2

Source: openFDA MAUDE database, through . 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.