Cleared Traditional

PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE

K861997 · Hazleton Research Products, Inc. · Microbiology
Jun 1986
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K861997 is an FDA 510(k) clearance for the PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE, a Supplement, Culture Media (Class I — General Controls, product code JSK), submitted by Hazleton Research Products, Inc. (Denver, US). The FDA issued a Cleared decision on June 10, 1986, 18 days after receiving the submission on May 23, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2450.

Submission Details

510(k) Number K861997 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 1986
Decision Date June 10, 1986
Days to Decision 18 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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