CAMPYLOCACTER SUPPLEMENT— 510(k) K843653

Substantially Equivalent

Institute Virion , Ltd.

FDA 510(k) clearance K843653 for CAMPYLOCACTER SUPPLEMENT, Substantially Equivalent on 1984-10-23. Applicant: Institute Virion , Ltd..

Clearance details

Applicant
Institute Virion , Ltd.
Product code
Code JSJ
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Oakland, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JSJ

product code JSJ
Malfunction
520
Total
520

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.