510(k) K880918— CAPTIA TOXO-G

Substantially Equivalent

Mercia Diagnostics , Ltd.

Clearance details

Applicant
Mercia Diagnostics , Ltd.
Product code
Code LGD
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Guildford, Surrey England, GB
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.