COBAS CORE TSH EIA— 510(k) K930776

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K930776 for COBAS CORE TSH EIA, Substantially Equivalent on 1993-12-03. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1993-02-16
Decision date: 1993-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

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.