STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY— 510(k) K850570

Substantially Equivalent

American Dade

FDA 510(k) clearance K850570 for STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY, Substantially Equivalent on 1985-04-02. Applicant: American Dade.

Clearance details

Applicant: American Dade
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1985-02-13
Decision date: 1985-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

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.