STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY— 510(k) K862428

Substantially Equivalent

American Dade

FDA 510(k) clearance K862428 for STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY, Substantially Equivalent on 1986-08-19. Applicant: American Dade.

Clearance details

Applicant: American Dade
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1986-06-26
Decision date: 1986-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.