SHIELD HELICO-G2 ELISA KIT— 510(k) K972981

Substantially Equivalent

Shield Diagnostics, Ltd.

FDA 510(k) clearance K972981 for SHIELD HELICO-G2 ELISA KIT, Substantially Equivalent on 1998-03-17. Applicant: Shield Diagnostics, Ltd..

Clearance details

Applicant: Shield Diagnostics, Ltd.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 1997-08-11
Decision date: 1998-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code LYR

product code LYR

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.