COTUBE(TM) TSH IRMA— 510(k) K890802

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K890802 for COTUBE(TM) TSH IRMA, Substantially Equivalent on 1989-03-28. Applicant: Bio-Rad.

Clearance details

Applicant: Bio-Rad
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1989-02-16
Decision date: 1989-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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.