Cleared Traditional

K942267 - DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE
(FDA 510(k) Clearance)

K942267 · Baxter Diagnostics, Inc. · Microbiology
Jan 1995
Decision
244d
Days
Class 2
Risk

K942267 is an FDA 510(k) clearance for the DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE. This device is classified as 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, 244 days after receiving the submission on May 10, 1994.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K942267 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 1994
Decision Date January 09, 1995
Days to Decision 244 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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