CENTRIA TSH RIA— 510(k) K791855

Substantially Equivalent

Union Carbide Corp.

FDA 510(k) clearance K791855 for CENTRIA TSH RIA, Substantially Equivalent on 1979-10-17. Applicant: Union Carbide Corp..

Clearance details

Applicant
Union Carbide Corp.
Product code
Code JLW
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView 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.