K-number	K052694
Device name	ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
Applicant	Ind Diagnostic, Inc.
Product code	JHI
Device class	Class II
Decision date	Dec 16, 2005
Decision	Substantially Equivalent
Regulation	862.1155

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ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.

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