K-number	K905857
Device name	HELENA THROMBOPLASTIN REAGENT, MODIFICATION
Applicant	Helena Laboratories
Product code	GJS
Device class	Class II
Decision date	Feb 27, 1991
Decision	Substantially Equivalent
Regulation	864.7750

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 →

HELENA THROMBOPLASTIN REAGENT, MODIFICATION

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