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510(k) K251697

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip by ACON Laboratories, Inc. — Product Code GTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2025
Date Received
June 2, 2025
Clearance Type
Dual Track
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, All Groups, Streptococcus Spp.
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type

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Other clearances for product code GTY

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  • K171976 — Sofia Strep A+ FIA, Sofia 2 Analyzer (December 21, 2017)
  • K141775 — SOFIA (R) STREP A+ FIA (December 16, 2014)
  • K133343 — WONDFO RAPID STREP A TEST (January 31, 2014)
  • K123793 — SOFIA STREP A FIA (June 17, 2013)
  • K122718 — BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP (February 6, 2013)
  • K091489 — CLEARVIEW ADVANCED STREP A , MODEL 737-430 (September 4, 2009)
  • K082661 — BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A (October 6, 2008)
  • K051638 — INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC (December 6, 2005)
  • K040708 — STATUS FIRST STREP A (November 22, 2004)