Cleared Traditional

OPUS(R) VANCOMYCIN

K924957 · Pb Diagnostic Systems, Inc. · Toxicology
Dec 1992
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K924957 is an FDA 510(k) clearance for the OPUS(R) VANCOMYCIN, a Radioimmunoassay, Vancomycin (Class II — Special Controls, product code LEH), submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on December 11, 1992, 72 days after receiving the submission on September 30, 1992. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3950.

Submission Details

510(k) Number K924957 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 1992
Decision Date December 11, 1992
Days to Decision 72 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LEH — Radioimmunoassay, Vancomycin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3950

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