ROTAG CONTROLS— 510(k) K900719

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K900719 for ROTAG CONTROLS, Substantially Equivalent on 1990-05-30. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1990-02-14
Decision date: 1990-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.