Cleared Traditional

BASE AGAR

K832576 · Acumedia Manufacturers, Inc. · Microbiology
Sep 1983
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K832576 is an FDA 510(k) clearance for the BASE AGAR, a Culture Media, Antibiotic Assay (Class I — General Controls, product code JSA), submitted by Acumedia Manufacturers, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983, 41 days after receiving the submission on August 2, 1983. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2350.

Submission Details

510(k) Number K832576 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 1983
Decision Date September 12, 1983
Days to Decision 41 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSA — Culture Media, Antibiotic Assay
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2350

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