Cleared Traditional

MICRODILUTION/LORACARBEF PANELS

K942089 · Baxter Diagnostics, Inc. · Microbiology
Jan 1995
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K942089 is an FDA 510(k) clearance for the MICRODILUTION/LORACARBEF 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 January 9, 1995, 252 days after receiving the submission on May 2, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K942089 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 1994
Decision Date January 09, 1995
Days to Decision 252 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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