Name: Predicase
Price: 199 USD

K-number	K080485
Device name	ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
Applicant	Diasys Diagnostics Systems GmbH
Product code	CIT
Device class	Class II
Decision date	Dec 4, 2008
Decision	Substantially Equivalent
Regulation	862.1100

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 →

ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS

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