WONDFO RAPID STREP A TEST— 510(k) K133343

Substantially Equivalent

Guangzhou Wondfo Biotech Co., Ltd.

FDA 510(k) clearance K133343 for WONDFO RAPID STREP A TEST, Substantially Equivalent on 2014-01-31. Applicant: Guangzhou Wondfo Biotech Co., Ltd..

Clearance details

Applicant: Guangzhou Wondfo Biotech Co., Ltd.
Product code: Code GTY
Advisory panel: Microbiology
Date received: 2013-10-30
Decision date: 2014-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

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.