K-number	K952283
Device name	AMERLITE HCG-60 ASSAY
Applicant	Johnson & Johnson Clinical Diagnostics, Inc.
Product code	DHA
Device class	Class II
Decision date	Jul 17, 1995
Decision	Substantially Equivalent
Regulation	862.1155

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View the full FDA submission: accessdata.fda.gov

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AMERLITE HCG-60 ASSAY

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