GAMMA-BCT INTACT PTH— 510(k) K942369

Substantially Equivalent

Immunodiagnostic Systems , Ltd.

FDA 510(k) clearance K942369 for GAMMA-BCT INTACT PTH, Substantially Equivalent on 1994-09-20. Applicant: Immunodiagnostic Systems , Ltd..

Clearance details

Applicant: Immunodiagnostic Systems , Ltd.
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 1994-05-18
Decision date: 1994-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tyne And Wear, GB

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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.