Cleared Traditional

PYLORISET

K904655 · Orion Diagnostica, Inc. · Microbiology
Oct 1991
Decision
374d
Days
Class 1
Risk

About This 510(k) Submission

K904655 is an FDA 510(k) clearance for the PYLORISET, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Orion Diagnostica, Inc. (02101 Espoo, FI). The FDA issued a Cleared decision on October 21, 1991, 374 days after receiving the submission on October 12, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K904655 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 1990
Decision Date October 21, 1991
Days to Decision 374 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

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

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