COTUBE PTH IRMA— 510(k) K921949

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K921949 for COTUBE PTH IRMA, Substantially Equivalent on 1992-09-02. Applicant: Bio-Rad.

Clearance details

Applicant: Bio-Rad
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 1992-04-27
Decision date: 1992-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CEW

product code CEW

Malfunction: 480
Total: 480

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.