PTH-MM II 125I RADIOIMMUNOASSAY (RIA)— 510(k) K901711

Substantially Equivalent

Incstar Corp.

FDA 510(k) clearance K901711 for PTH-MM II 125I RADIOIMMUNOASSAY (RIA), Substantially Equivalent on 1990-07-16. Applicant: Incstar Corp..

Clearance details

Applicant: Incstar Corp.
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 1990-04-13
Decision date: 1990-07-16
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.