Cleared Traditional

K153661 - ImmunoCard STAT! HpSA (FDA 510(k) Clearance)

K153661 · Meridian Bioscience, Inc. · Microbiology device

Mar 2016

Decision

84d

Days

Class 1

Risk

K153661 is an FDA 510(k) clearance for the ImmunoCard STAT! HpSA. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).

Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 14, 2016, 84 days after receiving the submission on December 21, 2015.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number	K153661 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 21, 2015
Decision Date	March 14, 2016
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement