Cleared Traditional

OPUS(R) SEROLOGY CONTROLS, MODIFICATION

K934137 · Pb Diagnostic Systems, Inc. · Microbiology
Mar 1994
Decision
194d
Days
Class 1
Risk

About This 510(k) Submission

K934137 is an FDA 510(k) clearance for the OPUS(R) SEROLOGY CONTROLS, MODIFICATION, a Kit, Serological, Positive Control (Class I — General Controls, product code MJX), submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on March 7, 1994, 194 days after receiving the submission on August 25, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K934137 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 1993
Decision Date March 07, 1994
Days to Decision 194 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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