VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY— 510(k) K983507

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K983507 for VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY, Substantially Equivalent on 1998-11-04. Applicant: Ortho-Clinical Diagnostics, Inc..

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 1998-10-07
Decision date: 1998-11-04
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.