Cleared Traditional

BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M

K811067 · Marion Laboratories, Inc. · Microbiology

Apr 1981

Decision

12d

Days

Class 2

Risk

About This 510(k) Submission

K811067 is an FDA 510(k) clearance for the BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M, a Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin (Class II — Special Controls, product code KZT), submitted by Marion Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 29, 1981, 12 days after receiving the submission on April 17, 1981. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number	K811067 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 1981
Decision Date	April 29, 1981
Days to Decision	12 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—

Device Classification

Product Code	KZT — Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3450