K954418

Substantially Equivalent

INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)

Applicant: Nichols Institute Diagnostics
Product code: CEW
Advisory panel: Clinical Chemistry
Date received: 1995-09-22
Decision date: 1995-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, 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.