Cleared Traditional

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS

K042303 · Ortho-Clinical Diagnostics · Microbiology
Sep 2004
Decision
33d
Days
Class 1
Risk

About This 510(k) Submission

K042303 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on September 27, 2004, 33 days after receiving the submission on August 25, 2004. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K042303 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 2004
Decision Date September 27, 2004
Days to Decision 33 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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