MUREX SUDS TOXO— 510(k) K861458

Substantially Equivalent

Murex Corp.

FDA 510(k) clearance K861458 for MUREX SUDS TOXO, Substantially Equivalent on 1986-06-13. Applicant: Murex Corp..

Clearance details

Applicant
Murex Corp.
Product code
Code LGD
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Norcross, GA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LGD

product code LGD
Malfunction
502
Total
502

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.