Cleared Traditional

DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL

K934323 · Baxter Diagnostics, Inc. · Microbiology
Oct 1994
Decision
411d
Days
Class 2
Risk

About This 510(k) Submission

K934323 is an FDA 510(k) clearance for the DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL, 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 October 19, 1994, 411 days after receiving the submission on September 3, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K934323 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1993
Decision Date October 19, 1994
Days to Decision 411 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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