VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)— 510(k) K965142

Substantially Equivalent

Johnson & Johnson Clinical Diagnostics, Inc.

FDA 510(k) clearance K965142 for VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15), Substantially Equivalent on 1997-03-18. Applicant: Johnson & Johnson Clinical Diagnostics, Inc..

Clearance details

Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 1996-12-23
Decision date: 1997-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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Adverse events under product code CEC

product code CEC

Malfunction: 899
Total: 899

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.