VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS— 510(k) K990026

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K990026 for VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS, Substantially Equivalent on 1999-01-29. Applicant: Ortho-Clinical Diagnostics, Inc..

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1999-01-05
Decision date: 1999-01-29
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.