Cleared Traditional

DRIED GRAM-POSITIVE MIC/COMBO PANELS

K945235 · Baxter Diagnostics, Inc. · Microbiology
Mar 1995
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K945235 is an FDA 510(k) clearance for the DRIED GRAM-POSITIVE 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 March 7, 1995, 131 days after receiving the submission on October 27, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K945235 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 1994
Decision Date March 07, 1995
Days to Decision 131 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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