CLEARVIEW ADVANCED STREP A , MODEL 737-430— 510(k) K091489

Name: FDA 510(k) clearance K091489
Creator: U.S. Food and Drug Administration
Published: 2009-09-04

Substantially Equivalent

Binax, Inc.

FDA 510(k) clearance K091489 for CLEARVIEW ADVANCED STREP A , MODEL 737-430, Substantially Equivalent on 2009-09-04. Applicant: Binax, Inc.. Device class: 1.

Clearance details

Applicant: Binax, Inc.
Product code: Code GTY
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 2009-05-20
Decision date: 2009-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough, ME, 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.