Cleared Traditional

K110745 - HELICOBACTER PYLORI ELISA IGG TEST KIT
(FDA 510(k) Clearance)

K110745 · Gold Standard Diagnostics · Microbiology

Mar 2012

Decision

351d

Days

Class 1

Risk

K110745 is an FDA 510(k) clearance for the HELICOBACTER PYLORI ELISA IGG TEST KIT, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Gold Standard Diagnostics (Davis, US). The FDA issued a Cleared decision on March 2, 2012, 351 days after receiving the submission on March 17, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number	K110745 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 2011
Decision Date	March 02, 2012
Days to Decision	351 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF