K091489

Substantially Equivalent

CLEARVIEW ADVANCED STREP A , MODEL 737-430

Applicant: Binax, Inc.
Product code: GTY
Advisory panel: Microbiology
Date received: 2009-05-20
Decision date: 2009-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough, ME, 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.