Cleared Traditional

GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)

K861824 · Flow Laboratories, Inc. · Microbiology
May 1986
Decision
8d
Days
Class 1
Risk

About This 510(k) Submission

K861824 is an FDA 510(k) clearance for the GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN), a Supplement, Culture Media (Class I — General Controls, product code JSK), submitted by Flow Laboratories, Inc. (Mclean, US). The FDA issued a Cleared decision on May 20, 1986, 8 days after receiving the submission on May 12, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2450.

Submission Details

510(k) Number K861824 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 1986
Decision Date May 20, 1986
Days to Decision 8 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSK — Supplement, Culture Media
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2450

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