Name: Predicase
Price: 199 USD

K-number	K142994
Device name	IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers
Applicant	Immunodiagnostic Systems , Ltd.
Product code	CJM
Device class	Class II
Decision date	Apr 21, 2015
Decision	Substantially Equivalent
Regulation	862.1045

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 →

IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers

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