K060348

Substantially Equivalent

MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT

Applicant: Scantibodies Laboratory, Inc.
Product code: CEW
Advisory panel: Clinical Chemistry
Date received: 2006-02-10
Decision date: 2006-02-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Santee, 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.