CIBA CORNING MAGIC LITE INTACT PTH IMMUNOASSAY— 510(k) K882560

Substantially Equivalent

Ciba Corning Diagnostics Corp.

FDA 510(k) clearance K882560 for CIBA CORNING MAGIC LITE INTACT PTH IMMUNOASSAY, Substantially Equivalent on 1988-10-13. Applicant: Ciba Corning Diagnostics Corp..

Clearance details

Applicant: Ciba Corning Diagnostics Corp.
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 1988-06-21
Decision date: 1988-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Walpole, MA, 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.