510(k) K111188— COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B

Substantially Equivalent

Roche Diagnostics

Clearance details

Applicant: Roche Diagnostics
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 2011-04-27
Decision date: 2012-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Adverse events under product code CHL

product code CHL

Death: 20
Malfunction: 999
Total: 1,019

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.