Cleared Traditional

K855172 - KWI (TM) G-CO/TWO
(FDA 510(k) Clearance)

K855172 · Micro-Bio-Logics · Microbiology

Feb 1986

Decision

56d

Days

Class 1

Risk

K855172 is an FDA 510(k) clearance for the KWI (TM) G-CO/TWO, a Supplement, Culture Media (Class I — General Controls, product code JSK), submitted by Micro-Bio-Logics (St. Cloud, US). The FDA issued a Cleared decision on February 20, 1986, 56 days after receiving the submission on December 26, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2450.

Submission Details

510(k) Number	K855172 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 1985
Decision Date	February 20, 1986
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—