BHCG-ROCHE EIA— 510(k) K850727

Substantially Equivalent

Hoffmann-La Roche, Inc.

FDA 510(k) clearance K850727 for BHCG-ROCHE EIA, Substantially Equivalent on 1985-06-25. Applicant: Hoffmann-La Roche, Inc..

Clearance details

Applicant: Hoffmann-La Roche, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1985-02-22
Decision date: 1985-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nutley, NJ, US

Download summary PDF View on FDA.gov ↗

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.