N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)— 510(k) K874299

Substantially Equivalent

Incstar Corp.

FDA 510(k) clearance K874299 for N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA), Substantially Equivalent on 1987-11-23. Applicant: Incstar Corp..

Clearance details

Applicant: Incstar Corp.
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 1987-10-20
Decision date: 1987-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

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Adverse events under product code CEW

product code CEW

Malfunction: 480
Total: 480

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.