Name: Predicase
Price: 199 USD

K-number	K251697
Device name	Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip
Applicant	ACON Laboratories, Inc.
Product code	GTY
Device class	Class I
Decision date	Nov 26, 2025
Decision	Substantially Equivalent
Regulation	866.3740

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

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

Everything you need for a 510(k) submission. Nothing you don't.