Name: Predicase
Price: 199 USD

K-number	K152122
Device name	Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)
Applicant	Alfa Scientific Designs, Inc.
Product code	DKZ
Device class	Class II
Decision date	Jun 24, 2016
Decision	Substantially Equivalent
Regulation	862.3100

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 →

Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)

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