Name: Predicase
Price: 199 USD

K-number	K992124
Device name	AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI
Applicant	Avanti Polar Lipids, Inc.
Product code	GMQ
Device class	Class II
Decision date	Sep 20, 1999
Decision	Substantially Equivalent
Regulation	866.3820

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Source

View the full FDA submission: accessdata.fda.gov

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AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI

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