Cleared Traditional

CASMAN MEDIUM BASE

K881527 · Acumedia Manufacturers, Inc. · Microbiology
Apr 1988
Decision
10d
Days
Class 2
Risk

About This 510(k) Submission

K881527 is an FDA 510(k) clearance for the CASMAN MEDIUM BASE, a Culture Media, For Isolation Of Pathogenic Neisseria (Class II — Special Controls, product code JTY), submitted by Acumedia Manufacturers, Inc. (Baltimore, US). The FDA issued a Cleared decision on April 18, 1988, 10 days after receiving the submission on April 8, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2410.

Submission Details

510(k) Number K881527 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 1988
Decision Date April 18, 1988
Days to Decision 10 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

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

Similar Devices — JTY Culture Media, For Isolation Of Pathogenic Neisseria

All 82
InTray GC
K210511 · Biomed Diagnostics Incorporated · Oct 2021
INTRAY GC
K993033 · Biomed Diagnostics, Inc. · Dec 1999
GC BASE W/ 1% GCHI
K954986 · Remel, L.P. · Feb 1996
CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
K950196 · Bioclinical Systems, Inc. · Jun 1995
MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR
K933122 · Bioclinical Systems, Inc. · Feb 1994
MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR
K933121 · Bioclinical Systems, Inc. · Feb 1994