COBAS(R) CORE T3 EIA— 510(k) K932608

Name: FDA 510(k) clearance K932608
Creator: U.S. Food and Drug Administration
Published: 1993-12-03

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K932608 for COBAS(R) CORE T3 EIA, Substantially Equivalent on 1993-12-03. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1993-05-28
Decision date: 1993-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

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.