Cleared Traditional

HP-FAST

K944903 · Gi Supply · Microbiology
Apr 1995
Decision
198d
Days
Class 1
Risk

About This 510(k) Submission

K944903 is an FDA 510(k) clearance for the HP-FAST, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Gi Supply (Camp Hill, US). The FDA issued a Cleared decision on April 20, 1995, 198 days after receiving the submission on October 4, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K944903 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 1994
Decision Date April 20, 1995
Days to Decision 198 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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

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