HYGEIA RAPID STREP A TEST— 510(k) K862133

Name: FDA 510(k) clearance K862133
Creator: U.S. Food and Drug Administration
Published: 1986-06-25

Substantially Equivalent

Hygeia Sciences

FDA 510(k) clearance K862133 for HYGEIA RAPID STREP A TEST, Substantially Equivalent on 1986-06-25. Applicant: Hygeia Sciences. Device class: 1.

Clearance details

Applicant: Hygeia Sciences
Product code: Code GTY
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 1986-06-04
Decision date: 1986-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton, MA, US

Download summary PDF View on FDA.gov ↗

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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.