VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III— 510(k) K042494

Name: FDA 510(k) clearance K042494
Creator: U.S. Food and Drug Administration
Published: 2004-10-19

Substantially Equivalent

Ortho-Clinical Diagnostics

FDA 510(k) clearance K042494 for VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III, Substantially Equivalent on 2004-10-19. Applicant: Ortho-Clinical Diagnostics. Device class: 2.

Clearance details

Applicant: Ortho-Clinical Diagnostics
Product code: Code CZW
Device class: Class 2
Regulation: 21 CFR 866.5240
Advisory panel: Immunology
Date received: 2004-09-14
Decision date: 2004-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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