Cleared Traditional

Hp Detect? Stool Antigen ELISA

K232892 · Biomerica, Inc. · Microbiology
Dec 2023
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K232892 is an FDA 510(k) clearance for the Hp Detect? Stool Antigen ELISA, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Biomerica, Inc. (Irvine, US). The FDA issued a Cleared decision on December 15, 2023, 88 days after receiving the submission on September 18, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K232892 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2023
Decision Date December 15, 2023
Days to Decision 88 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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