Name: Predicase
Price: 199 USD

K-number	K063798
Device name	DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000
Applicant	Diagnostic Hybrids, Inc.
Product code	GQN
Device class	Class II
Decision date	Sep 21, 2007
Decision	Substantially Equivalent
Regulation	866.3305

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 →

DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000

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