Name: Predicase
Price: 199 USD

K-number	K964787
Device name	MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM
Applicant	Mardx Diagnostics, Inc.
Product code	LLL
Device class	Class II
Decision date	Apr 8, 1997
Decision	Substantially Equivalent
Regulation	866.5100

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Source

View the full FDA submission: accessdata.fda.gov

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MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM

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