Name: Predicase
Price: 199 USD

K-number	K945610
Device name	ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP
Applicant	Princeton BioMeditech Corp.
Product code	DKZ
Device class	Class II
Decision date	Apr 13, 1995
Decision	Substantially Equivalent
Regulation	862.3100

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 →

ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP

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