AXSYM TOXO IGM— 510(k) K954576

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K954576 for AXSYM TOXO IGM, Substantially Equivalent on 1996-08-23. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1995-10-02
Decision date: 1996-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

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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.