Cleared Traditional

MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE

K896566 · Medical Specialties, Inc. · Microbiology
Feb 1990
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K896566 is an FDA 510(k) clearance for the MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Medical Specialties, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 9, 1990, 81 days after receiving the submission on November 20, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K896566 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 1989
Decision Date February 09, 1990
Days to Decision 81 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

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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