Cleared Traditional

VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III

K042494 · Ortho-Clinical Diagnostics · Immunology
Oct 2004
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K042494 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III, a Complement C3, Antigen, Antiserum, Control (Class II — Special Controls, product code CZW), submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on October 19, 2004, 35 days after receiving the submission on September 14, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K042494 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2004
Decision Date October 19, 2004
Days to Decision 35 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code CZW — Complement C3, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240

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