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

Name: FDA 510(k) clearance K063605
Creator: U.S. Food and Drug Administration
Published: 2007-06-21

Substantially Equivalent

Tosoh Bioscience, Inc.

FDA 510(k) clearance K063605 for ST AIA-PACK INTACT PTH ASSAY, Substantially Equivalent on 2007-06-21. Applicant: Tosoh Bioscience, Inc.. Device class: 2.

Clearance details

Applicant: Tosoh Bioscience, Inc.
Product code: Code CEW
Device class: Class 2
Regulation: 21 CFR 862.1545
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

Download summary PDF View on FDA.gov ↗

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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.