Cleared Traditional

ROCHE OXI/FERM II

K923313 · Roche Diagnostic Systems, Inc. · Microbiology
Apr 1993
Decision
272d
Days
Class 1
Risk

About This 510(k) Submission

K923313 is an FDA 510(k) clearance for the ROCHE OXI/FERM II, a Gram Negative Identification Panel (Class I — General Controls, product code LQM), submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on April 5, 1993, 272 days after receiving the submission on July 7, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K923313 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1992
Decision Date April 05, 1993
Days to Decision 272 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LQM — Gram Negative Identification Panel
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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