510(k) K862133— HYGEIA RAPID STREP A TEST

Substantially Equivalent

Hygeia Sciences

Clearance details

Applicant: Hygeia Sciences
Product code: Code GTY
Advisory panel: Microbiology
Date received: 1986-06-04
Decision date: 1986-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton, MA, US

Adverse events under product code GTY

product code GTY

Death: 2
Total: 2

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.