COBAS MFC— 510(k) K885292

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K885292 for COBAS MFC, Substantially Equivalent on 1989-03-22. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JQP
Advisory panel: Clinical Chemistry
Date received: 1988-12-27
Decision date: 1989-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JQP

product code JQP

Death: 3
Malfunction: 690
Total: 693

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.