VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS— 510(k) K983513

Name: FDA 510(k) clearance K983513
Creator: U.S. Food and Drug Administration
Published: 1998-11-03

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K983513 for VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS, Substantially Equivalent on 1998-11-03. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1998-10-07
Decision date: 1998-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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