Cleared Traditional

K945997 - MODIFIED FOX EXTRA GRAM POSITIVE
(FDA 510(k) Clearance)

K945997 · Micro-Media Systems, Inc. · Microbiology
Feb 1995
Decision
132d
Days
Class 2
Risk

K945997 is an FDA 510(k) clearance for the MODIFIED FOX EXTRA GRAM POSITIVE, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Micro-Media Systems, Inc. (Columbia, US). The FDA issued a Cleared decision on February 16, 1995, 132 days after receiving the submission on October 7, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K945997 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 1994
Decision Date February 16, 1995
Days to Decision 132 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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