Name: Predicase
Price: 199 USD

K-number	K201438
Device name	ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
Applicant	Arlington Scientific, Inc. (Asi)
Product code	GMQ
Device class	Class II
Decision date	Oct 21, 2020
Decision	Substantially Equivalent
Regulation	866.3820

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

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 →

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer

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