RIA TSH IN HUMAN SERUM OR PLASMA— 510(k) K781150

Substantially Equivalent

Diagnostic Corp. of America

FDA 510(k) clearance K781150 for RIA TSH IN HUMAN SERUM OR PLASMA, Substantially Equivalent on 1978-07-27. Applicant: Diagnostic Corp. of America.

Clearance details

Applicant
Diagnostic Corp. of America
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.