Cleared Traditional

K841220 - ANAEROBIC TRANSPORT MEDIUM (FDA 510(k) Clearance)

Apr 1984
Decision
13d
Days
Class 1
Risk

K841220 is an FDA 510(k) clearance for the ANAEROBIC TRANSPORT MEDIUM. This device is classified as a Culture Media, Anaerobic Transport (Class I - General Controls, product code JSL).

Submitted by Anaerobe Systems (Mchenry, US). The FDA issued a Cleared decision on April 4, 1984, 13 days after receiving the submission on March 22, 1984.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K841220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1984
Decision Date April 04, 1984
Days to Decision 13 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JSL — Culture Media, Anaerobic Transport
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2390

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