K-number	K011550
Device name	HCG STAT PAK ULTRA-FAST
Applicant	Chembio Diagnostic Systems, Inc.
Product code	JHI
Device class	Class II
Decision date	Aug 14, 2001
Decision	Substantially Equivalent
Regulation	862.1155

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View the full FDA submission: accessdata.fda.gov

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HCG STAT PAK ULTRA-FAST

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