INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY— 510(k) K963289

Substantially Equivalent

Incstar Corp.

FDA 510(k) clearance K963289 for INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY, Substantially Equivalent on 1997-05-01. Applicant: Incstar Corp..

Clearance details

Applicant: Incstar Corp.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1996-08-21
Decision date: 1997-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, 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.