Cleared Traditional

DRIED GRAM-POSITIVE MIC/COMBO PANELS

K934458 · Baxter Diagnostics, Inc. · Microbiology
Jul 1995
Decision
673d
Days
Class 2
Risk

About This 510(k) Submission

K934458 is an FDA 510(k) clearance for the DRIED GRAM-POSITIVE MIC/COMBO PANELS, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Baxter Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on July 18, 1995, 673 days after receiving the submission on September 13, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K934458 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 1993
Decision Date July 18, 1995
Days to Decision 673 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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