Name: Predicase
Price: 199 USD

K-number	K140717
Device name	CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT
Applicant	Siemens Healthcare Diagnostics
Product code	KQO
Device class	Class I
Decision date	Nov 17, 2014
Decision	Substantially Equivalent
Regulation	862.2900

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 →

CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT

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