Cleared Traditional

Ensol EnTM Specimen Collection and Transport System

K220908 · Ensol Biosciences, Inc. · Microbiology

Aug 2024

Decision

884d

Days

Class 1

Risk

About This 510(k) Submission

K220908 is an FDA 510(k) clearance for the Ensol EnTM Specimen Collection and Transport System, a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM), submitted by Ensol Biosciences, Inc. (Daejeon, KR). The FDA issued a Cleared decision on August 29, 2024, 884 days after receiving the submission on March 29, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number	K220908 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 29, 2022
Decision Date	August 29, 2024
Days to Decision	884 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF