QUANTA LITE TOXOPLASMA IGG— 510(k) K971441

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K971441 for QUANTA LITE TOXOPLASMA IGG, Substantially Equivalent on 1997-12-02. Applicant: Inova Diagnostics, Inc..

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1997-04-18
Decision date: 1997-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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.