K-number	K951850
Device name	ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT
Applicant	Helix Diagnostics, Inc.
Product code	LJM
Device class	Class II
Decision date	Jul 18, 1995
Decision	Substantially Equivalent
Regulation	866.5100

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 →

ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT

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