DeviceClearance

K153651

Substantially Equivalent

Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems

Applicant
Beckman Coulter, Inc.
Product code
JLW
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chaska, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code JLW

product code JLW
Malfunction
885
Total
885

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.