Cleared Traditional

DRIED GRAM-NEGATIVE MIC//COMBO PANELS

K935704 · Baxter Diagnostics, Inc. · Microbiology
Apr 1995
Decision
500d
Days
Class 2
Risk

About This 510(k) Submission

K935704 is an FDA 510(k) clearance for the DRIED GRAM-NEGATIVE MIC//COMBO PANELS, a Panels, Test, Susceptibility, Antimicrobial (Class II — Special Controls, product code LTT), submitted by Baxter Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on April 14, 1995, 500 days after receiving the submission on November 30, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K935704 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 1993
Decision Date April 14, 1995
Days to Decision 500 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LTT — Panels, Test, Susceptibility, Antimicrobial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

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