K-number	K991942
Device name	AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA
Applicant	Cogent Diagnotics , Ltd.
Product code	MLE
Device class	Class II
Decision date	Aug 24, 1999
Decision	Substantially Equivalent
Regulation	866.5110

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 →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA

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