K-number	K892706
Device name	SR1 (FSH) IMMUNOENZYMETRIC ASSAY
Applicant	Serono-Baker Diagnostics, Inc.
Product code	CGJ
Device class	Class I
Decision date	Jun 9, 1989
Decision	Substantially Equivalent
Regulation	862.1300

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View the full FDA submission: accessdata.fda.gov

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SR1 (FSH) IMMUNOENZYMETRIC ASSAY

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