Cleared Traditional

VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS

K030067 · Ortho-Clinical Diagnostics · Microbiology
Jan 2003
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K030067 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS, a Kit, Serological, Positive Control (Class I — General Controls, product code MJX), submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on January 17, 2003, 10 days after receiving the submission on January 7, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K030067 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2003
Decision Date January 17, 2003
Days to Decision 10 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MJX — Kit, Serological, Positive Control
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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