Name: Predicase
Price: 199 USD

K-number	K141274
Device name	QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS.
Applicant	Inova Diagnostics, Inc.
Product code	MSV
Device class	Class II
Decision date	Feb 13, 2015
Decision	Substantially Equivalent
Regulation	866.5660

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 ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS.

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