Name: Predicase
Price: 199 USD

K-number	K131330
Device name	GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT
Applicant	Gold Standard Diagnostics
Product code	LJM
Device class	Class II
Decision date	Jan 28, 2014
Decision	Substantially Equivalent
Regulation	866.5100

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 →

GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT

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