Cleared Traditional

HM-CAP CONTROL PANEL

K954926 · E-Z-Em, Inc. · Microbiology
Jan 1996
Decision
96d
Days
Class 1
Risk

About This 510(k) Submission

K954926 is an FDA 510(k) clearance for the HM-CAP CONTROL PANEL, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by E-Z-Em, Inc. (West Cadwell, US). The FDA issued a Cleared decision on January 30, 1996, 96 days after receiving the submission on October 26, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K954926 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 1995
Decision Date January 30, 1996
Days to Decision 96 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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