Cleared Dual Track

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

K251697 · ACON Laboratories, Inc. · Microbiology
Nov 2025
Decision
177d
Days
Class 1
Risk

About This 510(k) Submission

K251697 is an FDA 510(k) clearance for the Flowflex? Plus Strep A Rapid Test Cassette; Flowflex? Plus Strep A Rapid Test Strip, a Antigens, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTY), submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on November 26, 2025, 177 days after receiving the submission on June 2, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K251697 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2025
Decision Date November 26, 2025
Days to Decision 177 days
Submission Type Dual Track
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code GTY — Antigens, All Groups, Streptococcus Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3740

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