RIA SYSTEM, PARATHYROID HORMONE— 510(k) K782081

Substantially Equivalent

Iso-Tex Diagnostics

FDA 510(k) clearance K782081 for RIA SYSTEM, PARATHYROID HORMONE, Substantially Equivalent on 1979-03-21. Applicant: Iso-Tex Diagnostics.

Clearance details

Applicant: Iso-Tex Diagnostics
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 1978-12-13
Decision date: 1979-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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.