Name: Predicase
Price: 199 USD

K-number	K051058
Device name	METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
Applicant	Lin-Zhi International, Inc.
Product code	DJR
Device class	Class II
Decision date	Mar 29, 2006
Decision	Substantially Equivalent
Regulation	862.3620

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 →

METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS

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