Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip— 510(k) K251697

Substantially Equivalent

ACON Laboratories, Inc.

FDA 510(k) clearance K251697 for Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip, Substantially Equivalent on 2025-11-26. Applicant: ACON Laboratories, Inc..

Clearance details

Applicant: ACON Laboratories, Inc.
Product code: Code GTY
Advisory panel: Microbiology
Date received: 2025-06-02
Decision date: 2025-11-26
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: San Diego, CA, 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.