510(k) K063605— ST AIA-PACK INTACT PTH ASSAY

Substantially Equivalent

Tosoh Bioscience, Inc.

Clearance details

Applicant: Tosoh Bioscience, Inc.
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 2006-12-04
Decision date: 2007-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grove City, OH, 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.