PTH-RIA— 510(k) K844735

Substantially Equivalent

Syncor Intl. Corp.

FDA 510(k) clearance K844735 for PTH-RIA, Substantially Equivalent on 1985-04-29. Applicant: Syncor Intl. Corp..

Clearance details

Applicant: Syncor Intl. Corp.
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 1984-12-04
Decision date: 1985-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, 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.