K-number	K781786
Device name	QUANTICEL HHR # L500 AND L501
Applicant	Bhp Diagnostix, Inc.
Product code	JPK
Device class	Class II
Decision date	Nov 15, 1978
Decision	Substantially Equivalent
Regulation	864.8625

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 →

QUANTICEL HHR # L500 AND L501

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