Cleared Traditional

SHIELD HELICO-G2 ELISA KIT

K972981 · Shield Diagnostics, Ltd. · Microbiology
Mar 1998
Decision
218d
Days
Class 1
Risk

About This 510(k) Submission

K972981 is an FDA 510(k) clearance for the SHIELD HELICO-G2 ELISA KIT, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on March 17, 1998, 218 days after receiving the submission on August 11, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K972981 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1997
Decision Date March 17, 1998
Days to Decision 218 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

Similar Devices — LYR Helicobacter Pylori

All 90
Hp Detect? Stool Antigen ELISA
K232892 · Biomerica, Inc. · Dec 2023
Premier HpSA Flex (619096)
K230901 · Meridian Bioscience, Inc. · Jul 2023
Curian HpSA, Curian Analyzer
K192817 · Meridian Bioscience, Inc. · Mar 2020
Vstrip H. pylori Antigen Rapid Test
K183573 · Panion & BF Biotech, Inc. · Mar 2019
PREMIER Platinum HpSA PLUS
K182559 · Meridian Bioscience, Inc. · Nov 2018
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
K181464 · DiaSorin, Inc. · Aug 2018