K-number	K874267
Device name	REVISED LABELING FOR PCP TEST KIT
Applicant	Roche Diagnostic Systems, Inc.
Product code	LCM
Device class	Class U
Decision date	Nov 13, 1987
Decision	Substantially Equivalent
Regulation	—

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REVISED LABELING FOR PCP TEST KIT

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