COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2— 510(k) K123726

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K123726 for COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2, Substantially Equivalent on 2013-05-21. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 2012-12-04
Decision date: 2013-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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Adverse events under product code JGS

product code JGS

Malfunction: 535
Total: 535

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.