
ACON Laboratories, Inc.
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Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip is an FDA 510(k)-cleared medical device (K251697) manufactured by ACON Laboratories, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 25, 2025. Regulation: 8.

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