K-number	K911826
Device name	IMMUNOCARD HCG ONE STEP (I-S) TEST KIT
Applicant	Disease Detection International, Inc.
Product code	JHI
Device class	Class II
Decision date	Jul 19, 1991
Decision	Substantially Equivalent
Regulation	862.1155

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IMMUNOCARD HCG ONE STEP (I-S) TEST KIT

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