Cleared Traditional

CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA

K950196 · Bioclinical Systems, Inc. · Microbiology
Jun 1995
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K950196 is an FDA 510(k) clearance for the CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA, a Culture Media, For Isolation Of Pathogenic Neisseria (Class II — Special Controls, product code JTY), submitted by Bioclinical Systems, Inc. (Annapolis Junction, US). The FDA issued a Cleared decision on June 30, 1995, 163 days after receiving the submission on January 18, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2410.

Submission Details

510(k) Number K950196 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 1995
Decision Date June 30, 1995
Days to Decision 163 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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