Name: Predicase
Price: 199 USD

K-number	K143754
Device name	QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3
Applicant	Inova Diagnostics, Inc.
Product code	NHX
Device class	Class II
Decision date	Sep 21, 2015
Decision	Substantially Equivalent
Regulation	866.5775

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 →

QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3

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