Cleared Traditional

DRIED GRAM-POSITIVE MIC/COMBO PANELS

K943510 · Baxter Diagnostics, Inc. · Microbiology
Dec 1994
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K943510 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. (Mcgaw Park, US). The FDA issued a Cleared decision on December 2, 1994, 135 days after receiving the submission on July 20, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K943510 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1994
Decision Date December 02, 1994
Days to Decision 135 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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