K-number	K970177
Device name	ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA
Applicant	Immco Diagnostics, Inc.
Product code	MID
Device class	Class II
Decision date	Jun 11, 1997
Decision	Substantially Equivalent
Regulation	—

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ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA

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