COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2— 510(k) K132418

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K132418 for COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2, Substantially Equivalent on 2013-12-18. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 2013-08-02
Decision date: 2013-12-18
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.