K-number	K940549
Device name	ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
Applicant	Bio-Rad Laboratories, Inc.
Product code	CEP
Device class	Class I
Decision date	Apr 6, 1994
Decision	Substantially Equivalent
Regulation	862.1485

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View the full FDA submission: accessdata.fda.gov

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ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY

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