Cleared Traditional

GC BASE W/ 1% GCHI

K954986 · Remel, L.P. · Microbiology
Feb 1996
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K954986 is an FDA 510(k) clearance for the GC BASE W/ 1% GCHI, a Culture Media, For Isolation Of Pathogenic Neisseria (Class II — Special Controls, product code JTY), submitted by Remel, L.P. (Lenexa, US). The FDA issued a Cleared decision on February 16, 1996, 108 days after receiving the submission on October 31, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2410.

Submission Details

510(k) Number K954986 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 1995
Decision Date February 16, 1996
Days to Decision 108 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JTY — Culture Media, For Isolation Of Pathogenic Neisseria
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.2410

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