Cleared Traditional

K862123 - BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE
(FDA 510(k) Clearance)

K862123 · Marion Laboratories, Inc. · Microbiology

Jun 1986

Decision

13d

Days

Class 1

Risk

K862123 is an FDA 510(k) clearance for the BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE, 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 June 16, 1986, 13 days after receiving the submission on June 3, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2580.

Submission Details

510(k) Number	K862123 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 1986
Decision Date	June 16, 1986
Days to Decision	13 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—