COTUBE HCG IRMA TEST— 510(k) K882155

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K882155 for COTUBE HCG IRMA TEST, Substantially Equivalent on 1988-08-08. Applicant: Bio-Rad.

Clearance details

Applicant: Bio-Rad
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1988-05-20
Decision date: 1988-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, 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.