Cleared Traditional

Vstrip H. pylori Antigen Rapid Test

K183573 · Panion & BF Biotech, Inc. · Microbiology

Mar 2019

Decision

83d

Days

Class 1

Risk

About This 510(k) Submission

K183573 is an FDA 510(k) clearance for the Vstrip H. pylori Antigen Rapid Test, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Panion & BF Biotech, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on March 14, 2019, 83 days after receiving the submission on December 21, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number	K183573 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2018
Decision Date	March 14, 2019
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF