Cleared Traditional

ANTIBIOTIC MEDIUM #5 STREPTOMYCIN ASSAY AGAR

K881536 · Acumedia Manufacturers, Inc. · Microbiology
Apr 1988
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K881536 is an FDA 510(k) clearance for the ANTIBIOTIC MEDIUM #5 STREPTOMYCIN ASSAY AGAR, a Culture Media, Antibiotic Assay (Class I — General Controls, product code JSA), 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 866.2350.

Submission Details

510(k) Number K881536 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 JSA — Culture Media, Antibiotic Assay
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2350

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