Cleared Traditional

BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE

K845008 · Marion Laboratories, Inc. · Microbiology
Mar 1985
Decision
69d
Days
Class 1
Risk

About This 510(k) Submission

K845008 is an FDA 510(k) clearance for the BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE, a Device, Gas Generating (Class I — General Controls, product code KZJ), submitted by Marion Laboratories, Inc. (Kansas City, US). The FDA issued a Cleared decision on March 5, 1985, 69 days after receiving the submission on December 26, 1984. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2580.

Submission Details

510(k) Number K845008 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 1984
Decision Date March 05, 1985
Days to Decision 69 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code KZJ — Device, Gas Generating
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2580

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