Cleared Traditional

MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR

K933122 · Bioclinical Systems, Inc. · Microbiology
Feb 1994
Decision
229d
Days
Class 2
Risk

About This 510(k) Submission

K933122 is an FDA 510(k) clearance for the MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR, 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 February 9, 1994, 229 days after receiving the submission on June 25, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2410.

Submission Details

510(k) Number K933122 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 1993
Decision Date February 09, 1994
Days to Decision 229 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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