VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS— 510(k) K033127

Substantially Equivalent

Ortho-Clinical Diagnostics

FDA 510(k) clearance K033127 for VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS, Substantially Equivalent on 2003-10-31. Applicant: Ortho-Clinical Diagnostics.

Clearance details

Applicant: Ortho-Clinical Diagnostics
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2003-09-30
Decision date: 2003-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, 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.