Name: Predicase
Price: 199 USD

K-number	K131645
Device name	INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
Applicant	Alfa Scientific Designs, Inc.
Product code	DKZ
Device class	Class II
Decision date	Oct 7, 2013
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 OF ABUSE URINE TEST (CUP, PANEL CASSETTE)

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