510(k) K921523— OPUS(R) TOXO-G TEST SYSTEM

Substantially Equivalent

Pb Diagnostics, Inc.

Clearance details

Applicant: Pb Diagnostics, Inc.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1992-03-31
Decision date: 1992-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Adverse events under product code LGD

product code LGD

Malfunction: 502
Total: 502

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.