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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 the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2025-11-26 under 510(k) 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. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K251697.

When did Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip receive FDA 510(k) clearance?

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

Who is the listed applicant for Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip?

The FDA 510(k) record lists ACON Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: GTY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260342AllTest Strep A Rapid TestHangzhou AllTest Biotech Co., Ltd.K212623Healgen Strep A Rapid Test Strip (Throat Swab)Healgen Scientific,, LLCK171976Sofia Strep A+ FIA, Sofia 2 AnalyzerQuidel Corporation

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.

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