Cleared Traditional

OPUS SEROLOGY CONTROLS

K925703 · Pb Diagnostics, Inc. · Microbiology
Apr 1993
Decision
147d
Days
Class 1
Risk

About This 510(k) Submission

K925703 is an FDA 510(k) clearance for the OPUS SEROLOGY CONTROLS, a Kit, Serological, Positive Control (Class I — General Controls, product code MJX), submitted by Pb Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on April 8, 1993, 147 days after receiving the submission on November 12, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K925703 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1992
Decision Date April 08, 1993
Days to Decision 147 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

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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