Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip

K-Number: K251697 · 2025-11-26

ApplicantACON Laboratories, Inc.
Decision Date2025-11-26
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip is a medical device manufactured by ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2025-11-26 under approval number K251697. The device is classified under product code GTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip?

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip is a medical device that received FDA 510(k) clearance on 2025-11-26. It is manufactured by ACON Laboratories, Inc.. The 510(k) number is K251697.

When was Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip approved by the FDA?

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip received FDA 510(k) clearance on 2025-11-26, under approval number K251697.

What company makes Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip?

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip is manufactured by ACON Laboratories, Inc..

What is the FDA product code for Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip?

The FDA product code for Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip is GTY.

Other Devices by ACON Laboratories, Inc.

K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System K170587On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis K181527On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System K180504Mission Lipid Panel Monitoring System K180196On Call Express Mobile Blood Glucose Monitoring System K192175On Call Express II Blood Glucose Monitoring System

View all 15 devices →

Related Devices (Code: GTY)

K171976Sofia Strep A+ FIA, Sofia 2 AnalyzerQuidel Corporation K212623Healgen Strep A Rapid Test Strip (Throat Swab)Healgen Scientific,, LLC K260342AllTest Strep A Rapid TestHangzhou AllTest Biotech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑