Cleared Traditional

DRIED GRAM-POSITIVE MIC/COMBO PANELS

K944651 · Baxter Diagnostics, Inc. · Microbiology
Nov 1994
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K944651 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 November 18, 1994, 53 days after receiving the submission on September 26, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K944651 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 1994
Decision Date November 18, 1994
Days to Decision 53 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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