Cleared Traditional

MINI-TIP CULTURETTE

K803298 · Marion Laboratories, Inc. · Microbiology
Jan 1981
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K803298 is an FDA 510(k) clearance for the MINI-TIP CULTURETTE, a System, Transport, Aerobic (Class I — General Controls, product code JTW), submitted by Marion Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on January 12, 1981, 13 days after receiving the submission on December 30, 1980. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K803298 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 1980
Decision Date January 12, 1981
Days to Decision 13 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JTW — System, Transport, Aerobic
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2900

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