LIAISON N-TACT PTH— 510(k) K033426

Substantially Equivalent

DiaSorin, Inc.

FDA 510(k) clearance K033426 for LIAISON N-TACT PTH, Substantially Equivalent on 2004-02-12. Applicant: DiaSorin, Inc..

Clearance details

Applicant
DiaSorin, Inc.
Product code
Code CEW
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Stillwater, MN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CEW

product code CEW
Malfunction
480
Total
480

Source: openFDA MAUDE database, through . 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.