Cleared Traditional

K200272 - Terragene Chemdye
(FDA 510(k) Clearance)

K200272 · Terragene S.A. · General Hospital

Jun 2020

Decision

147d

Days

Class 2

Risk

K200272 is an FDA 510(k) clearance for the Terragene Chemdye, a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by Terragene S.A. (Alvear, AR). The FDA issued a Cleared decision on June 30, 2020, 147 days after receiving the submission on February 4, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number	K200272 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 2020
Decision Date	June 30, 2020
Days to Decision	147 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement