K-number	K020914
Device name	ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
Applicant	Helena Laboratories
Product code	JBP
Device class	Class II
Decision date	May 23, 2002
Decision	Substantially Equivalent
Regulation	864.7140

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 →

ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770

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