Cleared Traditional

VARELISA HELICOBACTER PYLORI ANTIBODIES

K953873 · Elias U.S.A., Inc. · Microbiology
Aug 1996
Decision
379d
Days
Class 1
Risk

About This 510(k) Submission

K953873 is an FDA 510(k) clearance for the VARELISA HELICOBACTER PYLORI ANTIBODIES, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on August 30, 1996, 379 days after receiving the submission on August 17, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K953873 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 1995
Decision Date August 30, 1996
Days to Decision 379 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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