Name: Predicase
Price: 199 USD

K-number	K081319
Device name	DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	JIT
Device class	Class II
Decision date	Aug 4, 2008
Decision	Substantially Equivalent
Regulation	862.1150

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 →

DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56

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