RADIOIMMUNOASSAY THYROID STIM. HORM. KIT— 510(k) K810948

Substantially Equivalent

Endocrine-Metabolic Center

FDA 510(k) clearance K810948 for RADIOIMMUNOASSAY THYROID STIM. HORM. KIT, Substantially Equivalent on 1981-04-17. Applicant: Endocrine-Metabolic Center.

Clearance details

Applicant
Endocrine-Metabolic Center
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.