Cleared Traditional

K012411 - HP-ONE (FDA 510(k) Clearance)

K012411 · Gi Supply · Microbiology device
Sep 2001
Decision
57d
Days
Class 1
Risk

K012411 is an FDA 510(k) clearance for the HP-ONE. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).

Submitted by Gi Supply (Camp Hill, US). The FDA issued a Cleared decision on September 25, 2001, 57 days after receiving the submission on July 30, 2001.

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

Submission Details

510(k) Number K012411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2001
Decision Date September 25, 2001
Days to Decision 57 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LYR - Helicobacter Pylori
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.3110