VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS— 510(k) K063143

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K063143 for VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS, Substantially Equivalent on 2006-12-26. Applicant: Ortho-Clinical Diagnostics, Inc..

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code LFX
Advisory panel: Microbiology
Date received: 2006-10-16
Decision date: 2006-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.