Cleared Traditional

PYLORI IGG ELISA TEST SYSTEM

K961221 · Armkel, LLC · Microbiology
Jul 1996
Decision
132d
Days
Class 1
Risk

About This 510(k) Submission

K961221 is an FDA 510(k) clearance for the PYLORI IGG ELISA TEST SYSTEM, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Armkel, LLC (Frederick, US). The FDA issued a Cleared decision on July 30, 1996, 132 days after receiving the submission on March 20, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K961221 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 1996
Decision Date July 30, 1996
Days to Decision 132 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

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