Name: Predicase
Price: 199 USD

K-number	K201442
Device name	Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers
Applicant	Diatron Group
Product code	LAF
Device class	Class II
Decision date	Jul 31, 2020
Decision	Substantially Equivalent
Regulation	862.3610

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 →

Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers

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