Name: Predicase
Price: 199 USD

K-number	DEN040002
Device name	NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970
Applicant	Perkinelmer Life Sciences, Inc.
Product code	NQL
Device class	Class II
Decision date	Aug 24, 2004
Decision	Not Substantially Equivalent
Regulation	862.1055

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 →

NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970

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