K853784

Substantially Equivalent

C-TERMINAL PTH RIA KIT

Applicant: Diagnostic Systems Laboratories, Inc.
Product code: CEW
Advisory panel: Clinical Chemistry
Date received: 1985-09-09
Decision date: 1985-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Webster, TX, US

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.