Cleared Traditional

GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX

K941459 · Baxter Diagnostics, Inc. · Microbiology
Feb 1995
Decision
316d
Days
Class 2
Risk

About This 510(k) Submission

K941459 is an FDA 510(k) clearance for the GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Baxter Diagnostics, Inc. (Mcgaw Park, US). The FDA issued a Cleared decision on February 3, 1995, 316 days after receiving the submission on March 24, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K941459 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1994
Decision Date February 03, 1995
Days to Decision 316 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JWY — Manual Antimicrobial Susceptibility Test Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

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