Name: Predicase
Price: 199 USD

K-number	K974859
Device name	LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
Applicant	Diagnostic Chemicals , Ltd.
Product code	CFJ
Device class	Class II
Decision date	Jan 22, 1998
Decision	Substantially Equivalent
Regulation	862.1440

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 →

LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30

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